FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
TABLE OF CONTENTS
STUDY CATEGORY ................................................................................................... PAGE
CLINICAL TRIAL (N=161) ..................................................................................................... 2
BEHAVIORAL/SOCIAL/EPIDEMIOLOGIC (N=160) ............................................................. 44
BASIC SCIENCE/VIROLOGY (N=91) ................................................................................... 72
FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Clinical Trials
Community AIDS Resource, Inc. (Care Resource)
3510 Biscayne Boulevard, Suite 300
Miami, FL 33137
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
ViiV HealthCare/Pfizer A4001095: A multicenter,
randomized, double-blind,
comparative trial of
Maraviroc+Darunavir /Ritonavir
versus Emtricitabine/Tenofovir +
Darunavir /Ritonavir for the
treatment of antiretroviralnaïve HIV infected patients with
CCR5 Tropic HIV-1
Tobira Therapeutics -652-2-202:
A phase 2b,
multicenter, double blind
comparative study to evaluate
the efficacy, safety and
tolerability of Cenicriviroc in
HIV‐1 infected, antiretroviral
treatment‐naïve patients with
only CCR5‐tropic virus.
Participants will receive either
once‐daily 100 mg or 200 mg
doses of Cenicriviroc in
combination with Truvada or
once‐daily Sustiva plus Truvada.
PI: Steven Santiago, M.D
Contacts for further
information:
Leandro Pisani
305/576-1234 ext 276
lpisani@careresource.org
or
Milagros Rodriguez
305/576-1234 ext 244
mrodriguez@careresource
.org
PI: Steven Santiago, M.D
Contacts for further
information:
Leandro Pisani
305/576-1234 ext 276
lpisani@careresource.org
or
Milagros Rodriguez
305/576-1234 ext 244
mrodriguez@careresource
.org
Recruitment Begins
9/15/2011
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
ELIGIBILITY :
Men and women ≥ 18 yrs of age who have
never taken antiretroviral drugs and have
a viral load > 1000 copies/ml and
CD4 > 100 cells/mm3
Recruitment Begins
8/20/2011
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
Men and women >
18 years of age with CCR5-tropic virus by
GT and Trofile-ES who have never taken
antiretroviral drugs; viral load > 5,000
copies/ml and CD4 > 250 cells/mm3
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STUDY CATEGORY
PROJECT TITLE
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
Viiv HealthCare/ Pfizer A4001098: A multi-center,
randomized, blinded, placebocontrolled study to evaluate the
safety of Maraviroc in
combination with other
antiretroviral agents in HIV-1infected subjects co-infected
with Hepatitis C and/or
Hepatitis B virus.
PI: Luis Saenz D.O
EPZ113734 - A Prospective,
Randomized, Multicenter, OpenLabel Study to Compare the
Efficacy and Safety of
Simplifying from a Regimen of
Atazanavir + Ritonavir +
Tenofovir/Emtricitabine to
Atazanavir +
Abacavir/Lamivudine Without
Ritonavir for 48
PI: Steven Santiago, M.D.
Luis Saenz D.O.
GlaxoSmithKline -EPZ113734:
A prospective, randomized,
multicenter, open-label study to
compare the efficacy and safety
of simplifying from a regimen of
Atazanavir +
Ritonavir/Tenofovir/
Emtricitabine to Atazanavir +
Abacavir/ Lamivudine without
Ritonovir for 48 weeks in
virologically suppressed, HIV-
PI: Steven Santiago, M.D.
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
INVESTIGATORS
DEPARTMENT
Enrollment Open
Contacts for further
information:
Leandro Pisani
305/576-1234 ext 276
lpisani@careresource.org
or
Milagros Rodriguez
305/576-1234 ext 244
mrodriguez@careresource
.org
SCIENTIFIC AREA
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
≥ 18 yrs of age co-infected with Hepatitis C
or B and not receiving treatment. for
Hepatitis B or C. Undectectable viral load
for at least 3 months. No prior treatment
with Maraviroc or another CCR5
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Contacts for further
information:
Milagros Rodriguez
305/576-1234 ext 244
mrodriguez@careresource
.org
Contacts for further
information:
Leandro Pisani
305/576-1234 ext 276
lpisani@careresource.org
or
Milagros Rodriguez
305/576-1234 ext 244
mrodriguez@careresource
Enrollment Open
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
18 yrs of age who have been undetectable
for more than 3 months and receiving a
regimen of ATV/RTV (300mg/100 mg)
+TDF/FTC (300mg/200 mg) as initial or first
and only switch regimen for at least 6
months.
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INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
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STUDY CATEGORY
PROJECT TITLE
infected HLA-B 5701 negative
subjects
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
.org
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INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
UNIVERSITY OF CENTRAL FLORIDA
Presenter: Alexander M. Cole, Ph.D.
CLINICAL TRIAL
Contract with HIV Vaccine Trials
Network (HVTN) and Fred
Hutchinson Cancer Research
Center to process specimens for
study# HVTN505
Alexander M. Cole, Ph.D.
(PI of lab contract); Edwin
DeJesus, M.D. (PI of
clinical contract)
Microbiology and
Molecular Biology
cGLP laboratory processing for clinical trial
NOVA SOUTHEASTERN UNIVERSITY –6 Studies
Presenter: Isa Fernandez, Ph.D.
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
Young Hispanic Men – Entre
Culturas: Navigating Culture,
Identity and HIV Risk
Project POWER: A Health
Promotion and HIV Risk
Reduction Intervention for Black
Men.
Adolescent Trials Network for
HIV interventions
Risk Reduction for Urban
Substance Using MSM
A Self-Assessment Intervention
for Young Adult Polydrug Users
at Risk for HIV
Case Management Alternatives
for African American Women at
High Risk for HIV
Maria Isabel Fernandez,
Ph.D. G. Stephen Bowen,
M.D.
Maria Isabel Fernandez,
Ph.D
College of Osteopathic
Medicine
HIV prevention among young
Hispanic/Latino MSM
College of Osteopathic
Medicine
HIV prevention among black men who
have sex with men and women
Maria Isabel Fernandez,
Ph.D. G.
Steven P. Kurtz, Ron Stall,
Hilary L. Surratt
Steven P. Kurtz, Hilary L.
Surratt
College of Osteopathic
Medicine
Division of Applied
Interdisciplinary Studies
Division of Applied
Interdisciplinary Studies
HIV and adolescents (both infected and at
risk for HIV)
HIV, MSM, drug use National Institute on
Drug Abuse Grant # DA024579
HIV, young adults, drug use National
Institute on Drug Abuse Grant # DA019048
Hilary L. Surratt, Gladys
Ibanez
Division of Applied
Interdisciplinary Studies
HIV, women, drug use National Institute
on Drug Abuse Grant # DA013131
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
University of Miami Department of Medicine, Division of Infectious Diseases
Jackson Medical Towers, 8th Floor East
1500 NW 12th Avenue
Miami, FL 33136
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
ViiV HealthCare/Pfizer A4001095–1019: A multicenter,
randomized, double-blind trial
comparing Maraviroc +
Darunavir/ Ritonavir vs.
Emtricitabine/Tenofovir +
Darunavir/Ritonavir for the
treatment of antiretroviral naïve
HIV-infected patients with CCR5tropic HIV-1
P.I.: Dushyantha
Jayaweera, M.D.
Tobira Therapeutics -652: A
phase IIb,
multicenter, double blind
comparative study to evaluate
the efficacy, safety and
tolerability of Cenicriviroc in
HIV‐1 infected, antiretroviral
treatment naïve patients with
only CCR5‐tropic virus.
Participants will receive either
once‐daily 100 mg or 200 mg
doses of Cenicriviroc in
combination with Truvada or
once‐daily Sustiva plus Truvada
University of
Minnesota/Insight: Strategic
Timing of Anti-Retroviral
Treatment (START): A
P.I.: Dushyantha
Jayaweera, M.D.
Waiting for IRB approval
Contact for further
information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
Eligibility:
Men and women >
18 years of age with CCR5-tropic HIV-1
who have never taken antiretroviral drugs
and have a viral load > 1,000 copies/ml
and CD4 > 100 cells/mm3
Begins 9/1/2011
Contact for further
information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
P.I.: Michael Kolber, M.D.
Contact for further
information:
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
Men and women >
18 years of age with CCR5 tropic virus who
have never taken antiretroviral drugs; BMI
< 35 kg/m2,
viral load > 5,000 copies/ml and CD4 > 250
cells/mm3
Begins 9/15/2011
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
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STUDY CATEGORY
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
PROJECT TITLE
INVESTIGATORS
multicenter study of the
International Network for
Strategic Initiatives in Global
HIV Trials (INSIGHT)
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
Merck and Co. 35835: A
prospective, open-label, singlecenter pilot study to evaluate
the addition of Raltegravir to
established suppressive
antiretroviral therapy while
monitoring changes in markers
of immune activation among
HIV-1 infected individuals
without adequate immune
restoration.
Viiv HealthCare/Pfizer A4001098–1021: A multicenter,
randomized, blinded, placebocontrolled study to evaluate the
safety of Maraviroc in
combination with other
antretroviral agents in HIV-1
infected subjects co-infected
with Hepatitis C and/or
Hepatitis B virus.
University of Miami
Developmental Center for AIDS
Research: Recovery of latent
reservoirs after treatment for
lymphoma in HIV infected
patients (Pilot Study).
P.I.: Rafael Campo, M.D.
DEPARTMENT
Enrollment open
Contact for further
information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
P.I.: Dushyantha
Jayaweera, M.D.
Contact for further
information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
Eligibility:
Healthy HIV infected men and women > 18
years of age who have never taken
antiretroviral drugs or interleukin-2 and
have CD4 > 500 cells/mm3
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
Men and women > 18 years of age with
HIV-1. CD4 count < 350 cells/mm3 at time
of enrollment
Begins 9/15/2011
Contact for further
information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
P.I.s: Luis Espinoza,
M.D./Michael Kolber,
M.D.
SCIENTIFIC AREA
Enrollment Open
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
Men and women > 18 years of age who
are available for 148 weeks. Undetectable
viral load, detectable HCV RNA and/or
Hepatitis B positive. Treatment with
antiretroviral therapy excluding Ritonavir.
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
Men and women > 18 years of age. HIV+
lymphoma. On highly active antiretroviral
therapy. Non- detectable viral load <50.
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STUDY CATEGORY
PROJECT TITLE
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
Vitamin Study – Double-Blind,
randomized, placebo controlled
study of Livethesource® daily
multi-vitamin (MVI) compared
with standard MVI in patients
infected with HIV-1
INVESTIGATORS
P.I.: Dushyantha
Jayaweera, MD
DEPARTMENT
Waiting UM IRB approval
Contact for further
information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
SCIENTIFIC AREA
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
HIV-1 infected men and women > 18 yrs of
age. On stable highly active antiretroviral
therapy. CD4 <500 cells/mm3
University of Miami Department of Pediatrics, Division of Infectious Diseases and Immunology
Batchelor Children’s Institute, 1580 NW 10 Avenue Suite 287
Miami, Fl 33136
CLINICAL TRIAL
International Maternal
Pediatric Adolescent AIDS
Clinical Trials (IMPAACT) –
PROMISE Study: The study will
determine if women who receive
highly active antiretroviral
therapy (HAART) during
pregnancy and continue their
regimen after delivery will have
less morbidity and mortality
than those who only receive
HAART during pregnancy and
stop after delivery. The study
also will evaluate the likelihood
of developing resistance to HIV
meds in women who stop
compared with those who
continue HAART after delivery.
The study will supply
antiretroviral medications.
P.I.: Gwendolyn Scott,
M.D.
Enrollment open
MEDICATION TRIALS:
Eligibility:
Contact for further
information:
Patricia Bryan, R.N.
305/243-4447
PBryan@med.miami.edu
Pregnant women who have only taken
antiretroviral therapy in pregnancy and
have CD4 cells of 400 or higher.
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
University of Miami AIDS HIV Women’s Program
(Dept. Obstetrics and Gynecology)
Clinical Research Building
1120 NW 14th Street, 7th Floor
Miami, FL 33136
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
Tibotec. A single arm open
label study to assess the
pharmacokinetics of Rilpivirine
in HIV-1 pregnant women.
Tibotec. A single arm open
label study to assess the
pharmacokinetics of
Darunavir/Ritonavir and/or
Etravirine in HIV-1 pregnant
women
P.I.: Salih Yasin, M.D.
Enrollment open
Contact for further
information:
Yvette Rivero
305/243-2169
YRivero@med.miami.edu
P.I.: Salih Yasin, M.D.
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
Women ≥ 18 years of age who have never
taken antiretroviral drugs and are between
18-24 weeks pregnant.
Enrollment open
Contact for further
information:
Yvette Rivero
305/243-2169
YRivero@med.miami.edu
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
Women ≥ 18 years of age, with a history of
taking antiretroviral drugs, who are
between 18-24 weeks pregnant.
Wohlfeiler, Piperato & Associates, LLC
1613 Alton Road
Miami Beach, FL 33139
MEDICATION TRIALS: Treatment
Naïve – No PAST USE OF
ANTIRETROVIRAL THERAPY
Sangamo Biosciences
(selected as site – details
pending)
P.I.: Michael Wohlfeiler,
M.D.
Contact for further
information:
Selected as a site –
waiting for contract
approval
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
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INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
Daniel Guzman, CRC
305/538-1400 ext: 222
danielguzmanwpa@aol.co
m
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
Sangamo Biosciences
(selected as site – details
pending)
P.I.: Michael Wohlfeiler,
M.D.
Men and women >
18 years of age never taken antiretroviral
drugs and have a viral load > 2,500
copies/ml and CD4 > 500 cells/mm3
Selected as a site –
waiting for contract
approval
Contact for further
information:
Daniel Guzman, CRC
305/538-1400 ext: 222
danielguzmanwpa@aol.co
m
Gilead Sciences – GS-0118: A
phase III trial to characterize the
effect of Cobicistat-based
regimens in patients with mild
to moderate renal impairment.
P.I.: Michael Wohlfeiler,
M.D.
ViiV Healthcare –111762: A
multicenter, randomized,
double-blind study of the safety
and efficacy of GSK 1349572 (50
mg. once daily) versus
Raltegravir (400 mg. twice daily)
added to an optimized
background regimen.
P.I.: Michael Wohlfeiler,
M.D.
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
Men and women >
18 years of age never taken antiretroviral
drugs and have a viral load > 2,500
copies/ml and CD4 > 500 cells/mm3
Enrollment Open
Contact for further
information:
Daniel Guzman, CRC
305/538-1400 ext: 222
danielguzmanwpa@aol.co
m
Contact for further
information:
Daniel Guzman, CRC
305/538-1400 ext: 222
danielguzmanwpa@aol.co
m
SCIENTIFIC AREA
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
HIV infected men and women > 18 years of
age who have never taken antiretroviral
drugs, have a viral load > 1,000 copies, and
have mild to moderate renal impairment.
Enrollment Open
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
HIV-infected men and women >
18 years of age who are antiretroviral
experienced and are integrase inhibitor
naïve.
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INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
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STUDY CATEGORY
PROJECT TITLE
MEDICATION TRIALS:
Treatment experienced (history
of Current or Past Use of
Antiretroviral Therapy)
ViiV Healthcare – ASSURE: A
randomized phase 4 switch
study designed to compare the
efficacy and safety of
simplifying therapy from a
regimen of atazanavir (ATV) +
ritonavir (RTV) +
tenofovir/emtricitabine
(TDF/FTC) to a regimen of ATV +
abacavir sulfate/lamivudine
(ABC/3TC) without RTV in
virologically suppressed, HIV-1
infected subjects.
P.I.: Michael Wohlfeiler,
M.D.
Salix Pharmaceuticals –
CFHD3092: This study is being
conducted to evaluate the
safety and tolerability of
crofelemer 125 mg twice a day,
taken orally, over 48 weeks of
therapy in human
immunodeficiency virus-positive
(HIV+) subjects with diarrhea.
P.I.: Michael Wohlfeiler,
M.D.
Trials for HIV-Associated
Conditions
INVESTIGATORS
DEPARTMENT
Enrollment Open
Contact for further
information:
Daniel Guzman, CRC
305/538-1400 ext: 222
danielguzmanwpa@aol.co
m
SCIENTIFIC AREA
MEDICATION TRIALS: Treatment
experienced (history of Current or Past
Use of Antiretroviral Therapy)
Eligibility:
Men and women >
18 years of age. 1) TDF/3TC + ATV/r
(300/100 mg) must be patient’s initial
antiretroviral regimen or the first or
second switch regimen, 2) virologically
suppressed on TDF/FTC + ATV/r, 3) must
be HLA-B*5701 negative.
Enrollment open
Trials for HIV-Associated Conditions
Eligibility:
HIV-infected adults who have been on
antiretroviral therapy for at least 4 weeks
prior to screening with self-reported
presence of diarrhea
Contact for further
information:
Daniel Guzman, CRC
305/538-1400 ext: 222
danielguzmanwpa@aol.co
m
Miami Beach Community Health Center, Inc.
710 Alton Road
Miami Beach, FL 33139
Trials for HIV-Associated
Conditions
KOWA Research Institute –
NK-104-4.05US: A study
comparing Pitavastatin (4 mg.)
vs. Pravastatin (40 mg.) in HIVinfected subjects with
dyslipidemia.
P.I.: Mark Keller, M.D.
Contact for further
information:
Alice Lopez
305/866-8915
Enrollment open
Trials for HIV-Associated Conditions
E ligibility:
HIV-infected men and women, ages 18-70,
who have taken antiretroviral drugs for at
least 6 months. LDL > 130 mg. and < 220
mg. and triglyceride levels < 400.
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
University of Miami, AIDS Clinical Research Unit
Elliot Building, Room 2016
1800 NW 10th Avenue, Miami FL 33136
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
AIDS Clinical Trials Group –
5303: A phase-IIIb trial to
evaluate bone, immunologic,
virologic and neuro-cognitive
effects of Maraviroc-containing
antiretroviral therapy regimen
in patients infected with CCR5
tropic HIV-1
P.I.: Margaret Fischl, M.D.
MEDICATION TRIALS:
Treatment Naïve – No PAST USE
OF ANTIRETROVIRAL THERAPY
ViiV Healthcare/Pfizer UK-427:
A comparative study of
Maraviroc/ Darunavir/Ritonavir
vs. Truvada/Darunavir/
P.I.: Margaret Fischl, M.D.
Ritonavir in ARV-naïve
individuals with CCR5 tropic HIV1 infection
Trials for HIV-Associated
Conditions
Trials for HIV-Associated
Conditions
Expect to begin enrolling
9/2011
Contacts for further
information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
Enrollment Open
Contacts for further
information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
AIDS Clinical Trials Group – A5279: A phase-III trial of short
course Rifapentine/ Isoniazid for
the prevention of active
tuberculosis (TB) in HIV-infected
individuals with latent TB
infection.
P.I.: Margaret Fischl, M.D.
AIDS Clinical Trials Group A5247: A phase II clinical trial
to evaluate the safety,
tolerability and immune
P.I.: Margaret Fischl, M.D.
Eligibility:
Men and women > 18 years of age with
CCR5 tropic HIV-1 infection. Excludes
pregnant women and those with acute
hepatitis or pancreatitis, renal
insufficiency, HepB+ or CXCR4 HIV-virus.
Expected to begin
9/2011
Trials for HIV-Associated Conditions
Eligibility:
HIV-1 infection, positive TB test prior to
study entry. Excludes those with current
pregnancy, active TB within 2 years of
study entry, on P.I.-based or Raltegravir –
regimen; liver cirrhosis, acute hepatitis.
Enrollment open
Trials for HIV-Associated Conditions
Eligibility:
Men and women ≥ 18 yrs of age with a
history of shingles (herpes zoster in the
Contacts for further
information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
Contacts for further
information:
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
Eligibility:
Men and women >
18 years of age with documented CCR5
only virus. Excludes those who are HepB+, pregnant, weigh > 300 lbs., have bone
fractures related to osteoporosis or bone
fragility, or active drug or alcohol abuse.
MEDICATION TRIALS: Treatment Naïve –
No PAST USE OF ANTIRETROVIRAL
THERAPY
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
response of ZOSTAVAX® (Zoster
Vaccine Live) in HIV-1-infected
adults on combination ART.
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
DEPARTMENT
SCIENTIFIC AREA
past one year) who are taking combination
ARV therapy and have a viral load < 50
copies/ml and CD4 cell count ≥ 200
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
UNIVERSITY OF MIAMI – 28 Studies
Presenter: Savita Pahwa, M.D.
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
Adolescent Medicine Trials
Network for HIV/AIDS
Interventions, aka ATN
(longstanding collaborative NIH
research consortium continually
funded here since 2001
following previous 1994-2001
award for REACH Protocol)
International Maternal Pediatric
Adolescent AIDS Clinical Trials
Group
Miami HIV/AIDS Clinical
Therapeutic and Vaccine Trial
Unit
Atherosclerotic Risk and
Response to Exercise
Intervention in HIV+ Children
DIETARY INTAKES AND
PATTERNS, BIOMARKERS, AND
MATERNAL AND INFANT
OUTCOMES IN HIV
University of Miami Pediatric
Perinatal HIV/AIDS Clinical Trails
Unit
Florida Node Alliance of the
Drug Abuse Clinic Trials Network
AIDS Malignancy Consortium
University of Miami Core Site
NIAID IRAC: combination
influenza treatment in high risk
and low risk patients with acute
influenza
Lawrence B Friedman,
MD (PI)
Pediatrics/Division of
Adolescent Medicine
Youth 13-24 y/o with HIV infection or highrisk attributes (numerous therapeutic,
behavioral, and community studies that
continuously are introduced, implemented
and completed). No drug or treatment
protocols are open presently.
Charles Mitchell,
Gwendolyn Scott
Microbiology and
Immunology, Pediatrics
U01
Margaret Fischl
Medicine
NIAID
Tracie L. Miller
Pediatrics
NHLBI
Tracie L. Miller
Pediatrics
NICHD
Gwendolyn B. Scott
Pediatrics
NIAID
Jose Szapocznik
Epidemiology & Pub.
Health Med.
Therapeutics Research
NIDA
Therapeutics Research
NIAID
Juan Carlos Ramos
Margaret Fischl
Hector Bolivar
Jose Castro
Michelle Morris
NCI
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STUDY CATEGORY
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
Effect of Raltegravir on immune
activation, immune
reconstitution and gut microbial
translocation in patients with
chronic HIV infection
P1077HS:HAART Standard
Version of the PROMISE Study:
Promoting Maternal and Infant
Survival Everywhere
P1083: A Phase II/III Trial of
Lopinavir/Ritonavir Dosed
According to The WHO Pediatric
Weight band Dosing Guidelines
GS-US-236-0102 - A Phase 3,
Randomized, Double-Blind Study
to Evaluate the Safety and
Efficacy of
Elvitegravir/Emtricitabine/Tenof
ovir Disoproxil Fumarate/GS9350 Vs
Efavirenz/Emtricitabine/Tenofov
ir Disoproxil Fumarate in HIV-1
Infected, Antiretroviral
Treatment-Naïve Adults.
GS-US-216-0114: A Phase 3,
Randomized, Double-Blind Study
to Evaluate the Safety and
Efficacy of GS-9350-boosted
Atazanavir Versus Ritonavirboosted Atazanavir Each
Administered with
Emtricitabine/Tenofovir
Disoproxil Fumarate in HIV-1
Infected, Antiretroviral
Treatment-Naїve Adults
INVESTIGATORS
Rafael Campo
Savita Pahwa
Mario Stevenson
Rafael Campo
DEPARTMENT
SCIENTIFIC AREA
Novel therapeutics and
pathogenesis
Merck
IMPAACT Studies
The purpose of this study is to see if
pregnant women receiving highly active
antiretroviral treatment (HAART) to
prevent mother-to-child transmission of
HIV will be healthier if, after delivery, they
continue or stop HAART.
Medicine
Treatment comparison
Medicine
Naive
On-Going
Rafael Campo
On-Going
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
GS-US-264-0106-A Phase 3
Randomized Open-Label Study
to Evaluate Switching from
Regimens Consisting of a
Ritonavir-boosted Protease
Inhibitor and Two Nucleoside
Reverse Transcriptase Inhibitors
to Emtricitabine /Rilpivirine/
Tenofovir Disoproxil Fumarate
(FTC/RPV/TDF) Fixed-dose
Regimen in
Virologically -Suppressed, HIV-1
Infected
Patients
A4001067 - An International,
Multi-center, Prospective
Observational Study of the
safety of Maraviroc used with
Optimized Background Therapy
in Treatment-Experienced HIV-1
Infected Patients.
MIDAS - Maraviroc Plus
Darunavir/ritonavir Study for
treatment-Naïve Patients
Infected with R5 tropic HIV-1
based on Enhanced Sensitivity
Trofile
A4001098 – 1021 - A
MULTICENTER, RANDOMIZED,
BLINDED, PLACEBOCONTROLLED STUDY TO
EVALUATE THE SAFETY OF
MARAVIROC IN COMBINATION
WITH OTHER ANTIRETROVIRAL
AGENTS IN HIV-1-INFECTED
INVESTIGATORS
Rafael Campo
DEPARTMENT
SCIENTIFIC AREA
Medicine
Clinical Efficacy
Medicine
Clinical Efficacy
Jose Castro
Medicine
Clinical Efficacy
On-Going
Dushyantha Jayaweera
Medicine
Clinical Efficacy
New-Enrolling soon
Jose Castro
On-Going
New – Enrolling soon
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
SUBJECTS CO-INFECTED WITH
HEPATITIS C AND/OR HEPATITIS
B VIRUS
A0081244 – 1029 - A
RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED,
PARALLEL-GROUP,
MULTICENTER TRIAL OF
PREGABALIN VERSUS PLACEBO
IN THE TREATMENT OF
NEUROPATHIC PAIN
ASSOCIATED WITH HIV
NEUROPATHY (PREGABALIN
A0081244)
A0081251 – 1029 - AN OPENLABEL, EXTENSION SAFETY TRIAL
OF PREGABALIN IN SUBJECTS
WITH NEUROPATHIC PAIN
ASSOCIATED WITH HIV
NEUROPATHY.
TMC278-TiDP6-C215: A Phase
III, randomized, double-blind
trial of TMC278 25 mg q.d.
versus efavirenz 600 mg q.d. in
combination with a background
regimen containing 2
nucleoside/nucleotide reverse
transcriptase inhibitors in
antiretroviral-naïve HIV-1
infected subjects
TMC-278-TiDP6-C222 - An openlabel trial with TMC278 25 mg
q.d. in combination with a
background regimen containing
2 nucleoside/nucleotide reverse
INVESTIGATORS
Jose Castro
DEPARTMENT
SCIENTIFIC AREA
Medicine
Clinical Efficacy
Medicine
Clinical Efficacy
Enrolling
Jose Castro
Enrolling
Clinical Efficacy
Jose Castro
Medicine
Jose Castro
Medicine
Clinical Efficacy
New-Roll-over for C215
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
transcriptase inhibitors in HIV-1
infected subjects, who
participated in TMC278 clinical
trials.
A4001078 – 1045 - Pilot Study of
Novel Combination of Maraviroc
+ Atazanavir/ Ritonavir Vs.
Atazanavir/ Ritonavir +
Emtricitabine/ Tenofovir For The
Treatment Of Treatment Naïve
HIV-Infected Patients With R5
HIV-1
A4001095 – 1019 - A
MULTICENTER, RANDOMIZED,
DOUBLE-BLIND, COMPARATIVE
TRIAL OF MARAVIROC +
DARUNAVIR/RITONAVIR VERSUS
EMTRICITABINE/TENOFOVIR +
DARUNAVIR/RITONAVIR FOR
THE TREATMENT OF
ANTIRETROVIRAL-NAÏVE HIVINFECTED PATIENTS WITH CCR5TROPIC HIV-1
Protocol VX08-950-110: A Phase
2A, 2-Part, Randomized, Double
Blind, Placebo Controlled,
Parallel Group, Multicenter
Study of Telaprevir in
Combination with Peginterferon
Alfa-2a (Pegasys®) and Ribavirin
(Copegus®) in Subjects who
Have Chronic HCV-1/HIV-1 CoInfection and are TreatmentNaïve for Hepatitis C
A Phase 2b Randomized,
INVESTIGATORS
Dushyantha Jayaweera
DEPARTMENT
SCIENTIFIC AREA
Medicine
Clinical Efficacy
Medicine
Clinical Efficacy
On-Going
Dushyantha Jayaweera
New – On-Hold Per
Sponsor
Clinical Efficacy
Dushyantha Jayaweera
Medicine
On-Going
Dushyantha Jayaweera
Medicine
Clinical Efficacy
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
Double-Blind, Double-Dummy
Trial of 100 or 200 mg OnceDaily Doses of Cenicriviroc (CVC,
TBR-652) or Once-Daily EFV,
Each With Open-Label FTC/TDF
in HIV-1-Infected, Antiretroviral
Treatment-Naïve, Adult Patients
with Only CCR5-Tropic Virus
Recovery of Latent Reservoirs
After Treatment for Lymphoma
in HIV Infected Patients: A Pilot
Study
Strategic Timing of AntiRetroviral Treatment (START) - A
Multicenter Study of the
International Network for
Strategic Initiatives in Global HIV
Trials (INSIGHT)
Retaining HIV Positive Patients
in Medical Care: Test for
Intervention Strategies for HIV
Clinics (Phase II)
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
New – Enrolling soon
Luis Espinoza/Michael
Kolber
Enrolling
Medicine
Viral reservoirs
INSIGHT –multicenter
Michael Kolber
Medicine
New – Enrolling soon
Allan Rodriguez
Medicine
CDC retention in care
On-Going
UNIVERSITY OF SOUTH FLORIDA – 25 Studies
Presenter: John W. Sleasman, M.D.
CLINICAL TRIAL
Pfizer- A40001031. Phase I/II
trial on the use of maraviroc in
HIV infected children and
adolescents
CLINICAL TRIAL
NO1-HD-8-0001NIH/NICHD
Carina Rodriguez, MD (site
PI), John Sleasman, MD,
Patricia Emmanuel, MD,
Jorge Lujan, MD, Alicia
Marion, ARNP, Kenneth
Kavanagh, ARNP (CoInvestigators)
Patricia Emmanuel, MD
Pediatric Infectious
Diseases
CCR5 inhibitor for HIV treatment in HIV infected
children and adolescents
Pediatric Infectious
Multicenter clinical trial related to therapy, HIV
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STUDY CATEGORY
PROJECT TITLE
Pediatric AIDS Clinical Trials
Group (IMPAACT).
CLINICAL TRIAL
U01 HD040497-06 NIH,
Adolescent Trials Network
CLINICAL TRIAL
Changes in the B cell repertoire
following vaccination with novel
H1N1 inactivated influenza
vaccine in immune deficient
adolescents and young adults
chronically infected with HIV
Treatment De-intensification
and Residual HIV-1 in Youth.
(ATN 081)
Preservation & Expansion of Tcell Subsets Following HAART
De-intensification to
Atazanavir/ritonavir (ATN 061)
Longitudinal changes in
cardiovascular risk markers
among adolescents newly
infected with HIV (ATN 083)
Assessment of inflammatory
Markets Associated with
Neurocognitive impairment in
HIV-infected Adolescents (ATN
101)
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
(PI), Carina Rodriguez,
MD, John Sleasman, MD
Jorge Lujan, MD, Alicia
Marion, ARNP, Kenneth
Kavanagh, ARNP (CoInvestigators)
Patricia Emmanuel, MD
(PI), Diane Straub, MD,
John Sleasman, MD,
Carina Rodriguez, MD,
Jorge Lujan, MD, Alicia
Marion, ARNP, Kenneth
Kavanagh, ARNP (CoInvestigators)
Carina Rodriguez, MD (PI),
John Sleasman, MD, Li Yin,
PhD, Maureen Goodenow,
PhD
Diseases
related complications, vaccines, and perinatal
transmission.
Pediatric Infectious
Diseases
ATN is a national, multicenter research
network, to conduct research to explore
behavioral,
microbicidal,
prophylactic,
therapeutic, and vaccine modalities in HIVinfected and HIV at-risk adolescents, age 12
through 24
Pediatric Infectious
Diseases, Allergy
and Immunology
(USF) and Pathology
(UF)
Immunologic responses to H1N1 inactivated
influenza vaccine in HIV-infected adolescents
and young adults
John Sleasman
Allergy and
Immunology, USF
Effects of early treatment followed by
treatment deintensification. Sponsor: NICHD
John Sleasman
Allergy and
Immunology, USF
Early treatment of HIV during deintensification
to ATV/r.
Sponsor: NICHD
John Sleasman
Allergy and
Immunology, USF
Cardiovascular risks in HIV-infected
adolescents.
Sponsor: NICHD
John Sleasman
Allergy and
Immunology, USF
Neurocognitive impairment in HIV.
Sponsor: NICHD
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
A randomized placebo
controlled trial of probiotics to
lower microbial translocation &
immune activation in HIVinfected adolescents
ATN 081/083 Processing
Contracts – ATN Coordinating
Center
Leadership Group for Adolescent
Medicine Trials Network
Protocol #Hizentra Transition
Study
Impact of HIV-1 Genotype on
Therapy Response in Children
Randomized, Double-Blind,
Parallel-Group, PlaceboControlled Study to Assess the
Efficacy and Safety of
Crofelemer 125 mg, 250 mg and
500 mg Orally Twice Daily for
the Treatment of HIV-Associated
Diarrhea (ADVENT Trial)
A Phase III, randomized, doubleblind trial of TMC278 75 mg q.d.
versus efavirenz 600 mg q.d. in
combination with a fixed
background regimen consisting
of tenofovir disoproxil fumarate
and emtricitabine in
antiretroviral-naïve HIV-1
infected subjects
A Phase llb randomized, partially
blinded, dose-finding trial of
TMC278 in antiretroviral naïve
HIV-1 infected subjects
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
John Sleasman
Allergy and
Immunology, USF
LPS levels and immunity preservation.
Sponsor: NICHD
John Sleasman (PI)
Pediatrics
John Sleasman (PI)
Pediatrics
John Sleasman (PI)
Pediatrics
John Sleasman (PI)
Pediatrics
Beata Casanas (PI)
Internal Medicine
Complications, therapy GI: diarrhea
Beata Casanas (PI)
Internal Medicine
primary therapy
Beata Casanas (PI)
Internal Medicine
primary therapy
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
An Open-label, Multicenter,
Multiple-dose Pharmacokinetic
and 48-week Safety and Efficacy
Trial of Maraviroc in
Combination with Optimized
Background Therapy for the
Treatment of AntiretroviralExperienced CCR5-Tropic HIV-1
Infected Children 2-18 Years
A Phase 1B Study of the Safety
and Pharmacokinetics of
Ritonavir-Boosted Elvitegravir
(EVG/r) Plus a Background
Regimen (BR) in HIV-1 Infected,
Antiretroviral TreatmentExperienced Adolescents
International Maternal Pediatric
Adolescent AIDS Clinical Trials
Group
Adolescent Medicine Trials
Network II
Carina Rodriguez (PI)
Pediatrics
Primary therapy
Patricia Emmanuel (PI)
Pediatrics
pharmacokenetics, HIV therapy
Patricia Emmanuel (PI)
Pediatrics
Prevention of maternal to child transmission,
pediatric treatment studies
Patricia Emmanuel (PI)
Pediatrics
Efficacy and Safety of Vicriviroc
in HIV-Infected Treatment-Naïve
Subjects
A Phase II randomized, doubleblind, placebo-controlled trial to
investigate the efficacy,
tolerability and safety of
TMC125 as part of an ART
including TMC114/RTV and an
investigator-selected OBR in
HIV-1 infected subjects
A Phase 3, Randomized, DoubleBlind Study to Evaluate the
Safety and Efficacy of GS-3950-
Chararut Somboonwit (PI)
Multicenter trials group, prevention and
treatment studies in HIV at risk and infected
youth
primary therapy
Todd Wills (PI)
Internal Medicine
HIV therapy
Todd Wills (PI)
Internal Medicine
HIV therapy
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
boosted Atazanavir Versus
Ritonavir-boosted Atazanavir
Each Administered with
Emtricitabine/Tenofovir
Disoproxil Fumarate in HIV-1
Infected, Antiretroviral
Treatment Naive Adults
A Phase 3, Open-Label,
Multicenter Study of the Safety
of Ritonavir-Boosted GS-9137
(GS-9173/r) Administered in
Combination with Other
Antiretroviral Agents for the
Treatment of HIV-1 Infected
Subjects
A Phase 3, Randomizes, DoubleBlind, Study to Evaluate the
Safety and Efficacy of
Elivitegravir/Emtricitabine/Tenof
ovir disoproxil Fumarate-GS9350 Versus
Efavirenz/Emtriciitabane/
Tenofovir Disoproxil Fumarate in
HIV-1 Infected, Antiretroviral
Treatment-Naïve Adults
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Todd Wills (PI)
Internal Medicine
HIV therapy
Todd Wills (PI)
Internal Medicine
primary therapy
ORANGE COUNTY HEALTH DEPARTMENT – 2 Studies
Presenter: Gerald Horton, Jr. M.D.
CLINICAL TRIAL
CLINICAL TRIAL
INSIGHT PROTOCOL001Strategic Timing of
AntiRetroviral Treatment
(START); Version2. (Not Yet
Started)
Protocol AI424403: An openlabel, randomized study
evaluating a switch from a
Dr. Gerald Horton (PI), Dr.
Richard Solero and Dr. Nila
Desai (CoPIs)
HugMe Immunology
Clinic
HIV Adults Sponsor: NIH, University of
Minnesota, Washington DC International
Coordinating Center (ICC)
Dr. Nila Desai (PI) and Dr.
Richard Solero/ Dr. Lynn
Hopkins (CoPIs)
Central Immunology
Clinic
HIV Adults
Sponsor: Bristol-Myers Squibb
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
regimen of two nucleoside
reverse transcriptase inhibitors
plus any third agent to either a
regimen of Atazanavir/Ritonavir
once daily & Raltegravir twice
daily or to a regimen of
Atazanavir/Ritonavir once daily
& Tenofovir/Emtricitabine once
daily in virologically suppressed
HIV-1 infected subjects with
safety and/or tolerability issues
on their present treatment
regimen (Not Yet Started)
UNIVERSITY OF FLORIDA
Presenter: Maureen Goodenow, Ph.D.
CLINICAL TRIAL
Pharmacotherapy to reduce
hazardous drinking in HIVInfected women
Robert L. Cook (PI)
Epidemiology
Alcohol
FLORIDA INTERNATIONAL UNIVERSITY – 3 Studies
Presenter: Mario De La Rosa, Ph.D.
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CLINICAL TRIAL
Micronutrient Therapy in HIV+
Adults inPROJECT
Botswana.TITLE
Marianna Baum (PI) and
INVESTIGATORS
Adriana
Campa, Co-PI
CLINICAL TRIAL
Zinc Therapy in Zinc Deficient
HIV+ Drug Users
Supplements to this project:
Effect of Zinc Supplementation
on Cytokine Modulation, HIVHCV Coinfection and Antioxidant
Status
Marianna Baum, PI, and
Adriana Campa, Co-PI
CLINICAL TRIAL
"HIV-Risk Reduction for Teens in
Alcohol Treatment.”
Jonathan Tubman (PI)
STUDY CATEGORY
Robert Stempel
DEPARTMENT
College
of Public
Health and Social
Work (Recently
Completed Studies)
Robert Stempel
College of Public
Health and Social
Work (Recently
Completed Studies)
A seven-year clinical trial of micronutrient
rplementation inSCIENTIFIC
collaborationAREA
with the Harvard
School of Public Health and the BotswanaHarvard Partnership. Funded by NIDA
Robert Stempel
College of Public
Health and Social
Work (Recently
Completed Studies)
Randomized, clinical trial to evaluate the
efficacy of clinic-based HIV-risk reduction
intervention for multi-ethnic youth undergoing
outpatient treatment for alcohol and other drug
abuse problems; Funded by NIAAA
A seven-year clinical trial that compared the
effects of zinc /placebo supplementation on
HIV disease progression, and extended its
research objectives by funded supplemental
research into the effects of zinc in modulating
cytokine responses and decreasing oxidative
stress in HIV/HCV co-infection Funded by NIDA
VACCINE & GENE THERAPY INSTITUTE – FLORIDA – 3 Studies
Presenters: Rafick Pierre Sékaly, Ph.D. & Lydie Trautmann, Ph.D.
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
A Pilot Study Evaluating the
Addition of Raltegravir to
Established Suppressive
Antiretroviral Therapy while
Monitoring Changes in Markers
of Immune Activation among
HIV-1 Infected Individuals
Without Adequate Immune
Restoration
Recovery of latent reservoirs
after treatment for lymphoma in
HIV infected patients: A Pilot
Study
Evaluation of HAART initiation
during acute HIV infection on
HIV reservoir persistence
Dr Campo, Dr Stevenson,
Dr Dr. Pahwa, Dr.
Chomont
Microbiology and
Immunology and
University of Miami
(dcFAR)
HIV reservoirs
Dr. Espinoza, Dr. Kolber
and Dr. Ramos, Dr. Sekaly,
Dr. Chomont
Microbiology and
Immunology and
University of Miami
(dcFAR)
VGTI and US Military
HIV Research
Program
HIV reservoirs
Dr. Ananworanich, Dr.
Kim, Dr. Chomont, Dr.
Sekaly
HIV reservoirs
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
University of Florida Center for HIV/AIDS Research Education and Service (UF CARES) – 15 Studies
Presented by Mobeen Rathore, M.D.
CLINICAL TRIAL
Efficacy of an Accelerated, HighDose, Hepatitis B Immunization
Series in HIV-Infected Patients
Levonne Mitchell-Samon,
MD (PI) Sub-Investigators:
Michael Sands, MD, MPH
&TM Nilmarie Guzman,
MD Christina L. Bailey, MD
CLINICAL TRIAL
Strategic Timing of
AntiRetroviral Treatment
(START)
CLINICAL TRIAL
A Phase I/II, Multicenter, OpenLabel, Noncomparative Study of
the International Maternal,
Pediatric, Adolescent AIDS
Clinical Trials (IMPAACT) Group
to Evaluate the Safety,
Tolerability, Pharmacokinetics,
and Antiretroviral Activity of
Raltegravir (Isentress™, MK0518) in HIV-1 Infected Children
and Adolescents IMPAACT
P1066
A Phase II Safety and
Immunogenicity Study of
Quadrivalent Human Papilloma
Virus [TYPES 6, 11, 16, 18] L1
Virus-Like Particle [VLP] Vaccine
(GARDASIL®) in HIV-Infected
Children (greater or equal to) 7
to < 12 Years of Age P1047 Ver.
Michael Sands, MD, MPH
& TM Sub-Investigators:
Nilmarie Guzman, MD
Christina L. Bailey, MD
Mobeen Rathore, MD
Mobeen Rathore, MD
CLINICAL TRIAL
Mobeen Rathore, MD
Infectious Diseases
Division and
Department of
Health Boulevard
Comprehensive Care
Center
Infectious Diseases
Division
Hepatitis B Vaccination scheduling and dosing
in HIV-Infected Patients
Pediatrics
Keywords: HIV, Raltegravir in HIV-infected
children, teens
Pediatrics
HIV, HPV Vaccine
HIV and initiation of ART
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
1.0
A5240: A Phase II Study to
Evaluate the Immunogenicity
and Safety of a Quadrivalent
Human Papillomavirus Vaccine
in HIV-1-Infected Females
A5257: A Phase III Comparative
Study of Three Non-Nucleoside
Reverse Transcriptase Inhibitor
(NNRTI)-Sparing Antiretroviral
Regimens for Treatment-Naïve
HIV-1-Infected Volunteers (The
ARDENT Study: Atazanavir,
Raltegravir, or Darunavir with
Emtricitabine- Tenofovir for
Naïve Treatment)
An Open-label, Multicenter,
Multiple-dose Pharmacokinetic
& 48-week Safety & Efficacy
Trial of Marairoc in Combination
with Optimized Background
Therapy for the Treatment of
Antiretroviral-experienced CCR5tropic HIV-1 Infected Children 218 Years of Age (A4001031)
IMPAACT P1065: Phase I/II,
Study of Safety and
Immunogenicity of Quadrivalent
Meningococcal Conjugate
Vaccine (MCV-4) In HIV-Infected
Children and Youth
IMPAACT P1086 A Phase II Study
to Assess the Safety &
Immunogenicity of an
Inactivated A(H1N1) 2009
Monovalent Vaccine in HIV-1
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Mobeen Rathore, MD
Pediatrics
HIV, HPV Vaccine
Mobeen Rathore, MD
Pediatrics
HIV infected women; HIV medication study
Mobeen Rathore, MD
Pediatrics
HIV, maraviroc
Mobeen Rathore, MD
Pediatrics
HIV, meningococcal conjugate vaccine,
children, youth
Mobeen Rathore, MD
Pediatrics
HIV-infected pregnant women, H1N1 influenza
vaccine
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
Infected Pregnant Women
IMPAACT P1088: A Phase II
Study to Assess the Safety &
Immunogenicity of an
Inactivated Influenza A (H1N1)
2009 Monovalent Vaccine in
HIV-1 Perinatally Infected
Children & Youth
Phase III, Randomized Trial of
the Safety & Efficacy of Three
Neonatal Antiretroviral
Regimens for the Prevention of
Intrapartum HIV-1 Transmission
(NICHD/HPTN 040/P1043)
A5257: A Phase III Comparative
Study of Three Non-Nucleoside
Reverse Transcriptase Inhibitor
(NNRTI)-Sparing Antiretroviral
Regimens for Treatment-Naïve
HIV-1-Infected Volunteers (The
ARDENT Study: Atazanavir,
Raltegravir, or Darunavir with
Emtricitabine/Tenofovir for
Naïve Treatment)
An International, Multicenter,
Prospective Observational Study
of the Safety of Maraviroc used
with Optimized Background
Therapy in TreatmentExperienced HIV-1 Infected
Patients (POEM)
IMPACCT 1077 HS: HAART
Standard Version of the
PROMISE Study (Promoting
Maternal and Infant Survival
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Mobeen Rathore, MD
Pediatrics
HIV and H1N1
Mobeen Rathore, MD
Pediatrics
Mobeen Rathore, MD
Pediatrics
HIV infected women; HIV medication study
Nilmarie Guzman, MD (PI)
Sub-Investigators: Michael
Sands, MD, MPH & TM,
Christina L. Bailey, MD,
Levonne Mitchell-Samon,
MD
Catherine Rogers, PA-C
Ne’Tosha Dopson, PA-C
Infectious Diseases
Division
HIV-1; maraviroc safety in long-term use
Mobeen Rathore, MD
Pediatrics
HIV, post partum
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STUDY CATEGORY
CLINICAL TRIAL
PROJECT TITLE
INVESTIGATORS
Everywhere), Version 1.0
Pharmacotherapy for Hazardous
Drinking in HIV Infected Women:
Randomized Trial
Robert Cook, MD, MPH
and Mobeen Rathore, MD
DEPARTMENT
Pediatrics
SCIENTIFIC AREA
Hazardous Drinking Behavior, HIV, alcohol,
naltrexone
BROWARD CHILDREN’S DIAGNOSTIC & TREATMENT CENTER - 12 Studies
Presented by Ana Puga, M.D.
CLINICAL TRIAL
ATN 061: Preservation and
Expansion of T-cell Subsets
Following Highly Active
Antiretroviral Therapy (HAART)
De-intensification to
Atazanavir/ritonavir (ATV/r) in
Adolescents and Young Adults
with CD4 + T Cells > 350 and HIV
RNA < 100,000 Initiating HAART
Ana Puga, MD
Barbara Moscicki
CFAP Research
Antiretroviral Therapy (ART) in adolescents
Ana Puga, MD
CFAP Research
Human Papilloma Virus (HPV) vaccine in
adolescents
Ana Puga, MD
CFAP Research
HPV in Perinatally Infected Children/Youth
Ana Puga, MD
CFAP Research
HIV and Pregnancy
Postpartum Antiretroviral Treatment Strategy
Ana Puga, MD
CFAP Research
Pharmacokinetics of Newer Agents in
Children/Youth.
(on-going)
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
ATN 064: Immunogenicity, Safety,
Tolerability, and Behavioral
Consequences of an HPV-6,-11,16,-18 Vaccine in HIV-Infected
Young Women (closed)
Campbell Study: HPV Infections
and Associated Morbidity in
Children and Adolescents
Perinatally Infected with HIV
IMPAACT 1077HS: HAART
Standard Version of the PROMISE
Study (Promoting Maternal and
Infant Survival Everywhere)
(recruiting)
IMPAACT 1058A: Intensive
Pharmacokinetic Studies of New
Classes of Antiretroviral Drug
combinations in Children,
Adolescents and Young Adults
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
(recruiting)
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
IMPAACT 1066: A Phase I/II,
Multicenter, Open-Label,
Noncomparative Study of the
International Maternal, Pediatric,
Adolescent AIDS Clinical Trials
(IMPAACT) Group to Evaluate the
Safety, Tolerability,
Pharmacokinetics, and
Antiretroviral Activity of
Raltegravir (MK-0518) in HIV-1
Infected Children and Adolescents
(recruiting)
IMPAACT A5240: A Phase II Study
to Evaluate the Immunogenicity
and Safety of a Quadrivalent
Human Papillomavirus Vaccine in
HIV-1 Infected Females
(recruiting)
IMPAACT A5241: The Optimized
Treatment that Includes or Omits
NRTIs (OPTIONS) Trial: A
Randomized Strategy Study for
HIV-1 Infected TreatmentExperience Subjects Using the
cPss to Select an Effective
Regimen (recruiting)
IMPAACT A5257: A Phase III
Comparative Study of Three NonNucleoside Reverse Transcriptase
Inhibitor (NNRTI)-Sparing
Antiretroviral Regimens for
Treatment-Naïve HIV-1 Infected
Volunteers (recruiting)
Ana Puga, MD
CFAP Research
Raltegravir in Children
Pharmacokinetics
Ana Puga, MD
CFAP Research
HPV in Adult HIV positive females
Ana Puga, MD
CFAP Research
Salvage Antiretroviral Therapy (ART)
Ana Puga, MD
CFAP Research
Antiretroviral Therapy Strategy
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
IMPAACT P1063: Phase I/II Safety
and Efficacy Investigation of
Atorvastatin for Treatment of
Increased LDL Cholesterol In HIVInfected Children, Adolescents,
and Young Adults (recruiting)
IMPAACT P1093: A Phase I/II,
Multi-Center, Open-Label
Pharmacokinetic, Safety,
Tolerability and Antiviral Activity
of GSK1349572, A Novel Integrase
Inhibitor, in Combination
Regimens in HIV-1 Infected
Infants, Children and Adolescents.
2/9/2011 - Present (recruiting)
IMPAACT P1096: A Companion
Protocol to CIR Protocol Number:
CIR255
Phase 1 Study to Determine the
Safety, Infectivity,
Immunogenicity and Tolerability
of 2 Doses of Live Attenuated
Recombinant Cold-passaged (cp)
45 Human Parainfluenza Type 3
Virus Vaccine, rHPIV3cp45, Lot
PIV3#102A, Delivered as Nose
Drops to HPIV3-Seronegative
Infants and Children 6 to 36
Months of Age, at a 6 Month
Interval (recruiting)
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Ana Puga, MD
CFAP Research
Pharmacokinetics
Cholesterol treatment for children/youth
Ana Puga, MD
CFAP Research
Novel Intergrase in children
Pharmacokinetics
Ana Puga, MD
CFAP Research
Human Parainfluenza Vaccine in HIV negative
Children
ClinicalTrials.gov Website Studies – 39 Additional Studies
CLINICAL TRIAL
Sleep Quality and Presence of Sleep
Disordered Breathing In An Inner City
African American HIV Infected
Population Aged 50 Years and Older
Supriya Mannepalli, MD,
Akram Khan, MD
University of Florida
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
CLINICAL TRIAL
A Phase 2B Multicenter, Randomized,
Comparative Trial Of UK-453,061
Versus Etravirine In Combination With
Darunavir/Ritonavir And A
Nucleos(t)Ide Reverse Transcriptase
Inhibitor For The Treatment Of
Antiretroviral Experienced HIV-1
Infected Subjects With Evidence Of
NNRTI Resistant HIV-1
Study Director: Pfizer CT.gov
Call Center
CLINICAL TRIAL
A Study to Assess the
Pharmacokinetics (Blood Levels) of
TMC114 (Darunavir) Taken With
TMC114r (Ritonavir), and TMC125
(Etravirine) in HIV-1 Infected Pregnant
Women
NCT00855335
Optimizing Treatment for TreatmentExperienced, HIV-infected People
Tibotec, Inc. Clinical Trial
Recruiting: Daytona Beach,
Miami, Pensacola, Port St.
Lucie, West Palm Beach,
Florida
TMC125-TiDP2-C238: An Exploratory
Pharmacokinetics, Safety and AntiHIV Activity Study of Etravirine (ETR)
When Given With Boosted Atazanavir
Tibotec Pharmaceuticals
Clinical Trial, IRELAND
CLINICAL TRIAL
CLINICAL TRIAL
National Institute of Allergy
and Infectious Diseases
AIDS Clinical Trials Group
Karen T. Tashima, MD, Brown
University;
Richard H. Haubrich, MD,
Division of Infectious Diseases,
UCSD Antiviral Research Center
Recruiting: Orlando, Tampa,
DEPARTMENT
SCIENTIFIC AREA
Percentage of subjects with HIV-1 RNA <50 copies/mL at 24 weeks.; The
percentage of subjects with HIV-1 RNA <50 copies/mL and <400 copies/mL at
various time points; The change from baseline in log10 transformed HIV 1
RNA levels; Assessment of Genotypic and phenotypic resistance at various
time points; The time-averaged difference (TAD) in log10 transformed HIV 1
RNA levels at various time points.; The percentage of subjects with virologic
response at different time points.; Change from baseline in CD4+ cell counts
(absolute and percentage).; Safety and tolerability as measured by
spontaneous adverse event reports, serious adverse events and safety
laboratory tests.; Pharmacokinetic (PK) and
pharmacokinetic/pharmacodynamic (PK/PD) analyses (to be reported
separately). Sponsor: Pfizer
To assess the influence of pregnancy on the pharmacokinetics of
darunavir/ritonavir (darunavir/r) and/or etravirine during the second and
third trimesters of gestation, as well as postpartum; Changes in anti-viral
activity and safety and tolerability of darunavir/r and/or etravirine-based
antiretroviral regimens during gestation and postpartum; compare
darunavir/r and/or etravirine concentrations between serum and cord blood;
pregnancy outcome
Time to regimen failure; Toxicity, as defined as time to first Grade 3 or
higher (and one grade higher than baseline) signs/symptom or laboratory
abnormality; Tolerability, as defined as time to first dose modification, time
to permanent discontinuation of all study
drugs; Time to abandoning randomized NRTI strategy; Time to virological
failure, as defined by the protocol; Binary variable indication if viral load is
less than 50 copies/ml; Change in viral load; Binary variable indicating
acquisition of drug resistance mutations to any of the study
agents; Change in summarized quality of life score; Binomial indicator of
"perfect" adherence to assigned ARVs; Change in cardiovascular risk score
and fasting lipid values; Change in CD4 count; Time to serious nonAIDS events; Change in virus coreceptor tropism among those with R5-only
tropic virus in Step 1; HIV-1 coreceptor tropism; Binary indicator of undetectable CSF HIV1 RNA; Summarized continuous neuro-cognitive performance Zscores; Binary variable indicating whether CSF ARV drug concentrations are
above the population median; CPE score (CNS penetration effectiveness)
PK interaction between ETR and ATV/rtv at 2 different doses; safety &
tolerability of ETR in combination with ATV/rtv and 1 NRTI over 48
weeks.; Assessing the impact of cytochrome P450 (CYP) 2C9 and 2C19
genotypes on ETR PK; Evaluating safety and tolerability of ETR in
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
(ATV/Rtv) at Two Different Doses and
1 Nucleoside Reverse Transcriptase
Inhibitor (NRTI) in Treatment
Experienced HIV Patients
Vero Beach, West Palm Beach
Study to Evaluate the Safety and
Efficacy of a Single Tablet Regimen of
Emtricitabine/Rilpivirine/Tenofovir
Disoproxil Fumarate Compared With
a Single Tablet Regimen of
Efavirenz/Emtricitabine/Tenofovir
Disoproxil Fumarate in HIV-1 Infected,
Antiretroviral Treatment-Naïve
Adults.
Safety of and Immune Response to an
H1N1 Influenza Vaccine in HIV
Infected Pregnant Women
Alena Jandourek, M.D. Gilead
Sciences
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID)
Sharon Nachman, MD, State
University of New York at
Stony Brook
Pfizer CT.gov Call Center
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
Safety of and Immune Response to
the Human Papillomavirus (HPV)
Vaccine in HIV-Infected Women
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID); NATIONAL
INSTITUTE OF DENTAL AND
CRANIOFACIAL RESEARCH
(NIDCR)
Erna Milunka Kojic, MD,
Department of
Immunology/Infectious
Disease, The Miriam Hospital,
Brown University;
Susan Cu-Uvin, MD, ObstetricsGynecology and Medicine, The
Miriam Hospital, Brown
DEPARTMENT
SCIENTIFIC AREA
combination with ATV/r and 1 NRTI over 48 weeks; Evaluating the antiviral
activity of ETR and ATV/r with 1 NRTI over 48 weeks; Evaluating the
immunologic changes (as measured by CD4 cells) with ETR and ATV/r with 1
NRTI over 48 weeks; Evaluating changes in viral genotype and drug
susceptibility
The primary efficacy endpoint is the proportion of subjects who achieve HIV
1 RNA < 50 copies/mL at week 48; The change from baseline in CD4 count in
each treatment arm at week 48; The change from baseline in CD4 count in
each treatment arm at week 96
Adverse events (AEs) of all grades; AEs of all grades attributed to the study v
accine; Withholding of second vaccine dose due to adverse reactions
attributed to first dose; Immunologic response, defined as
hemagglutination inhibition (HAI) titer of at least 1:40; Maternal
immunologic response, defined as HAI of at least
1:40; Infant HAI of at least 1:40; Maternal geometric mean titers (GMT) of
antibodies HAI; Infant GMT of antibodies HAI; Maternal cell-mediated
immunity (CMI) responses, as measured by B-cell and T-cell enzyme-linked
immunosorbent spot (ELISPOT) assay
values; CD4 count; HIV RNA copies/ml; Response to seasonal trivalent
influenza vaccine (TIV); Exploration of factors related to HIV and its
treatment that might affect the response to H1N1 vaccinations
Type-specific HPV antibody development from the seronegative status at
baseline to seropositive status a month after the completion of HPV
vaccination series (Week 28) for HPV types 6, 11, 16, and
18; Occurrence of Grade 3 or greater adverse events; HPV antibody titers t
o types 6, 11, 16, 18; Longitudinal changes in HIV viral load; Nadir and base
line CD4 count; Baseline HIV viral load; Cellular immune response assay
data from the subset of U.S. participants; Longitudinal changes in CD4+ cell
count from baseline
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
University
CLINICAL TRIAL
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
CLINICAL TRIAL
An Open Label Pharmacokinetic,
Safety And Efficacy Study Of
Maraviroc In Combination With
Background Therapy For The
Treatment Of HIV-1 Infected, CCR5 Tropic Children
Safety and Effectiveness of
Raltegravir (MK-0518) in TreatmentExperienced, HIV-Infected Children
and Adolescents
The TMC125-C214 Study Provides
Early Access to TMC125 for HIV-1
Infected Patients Who Have Failed
Multiple Antiretroviral Regimens and
Will Also Gather Information on the
Long-term Safety and Tolerability of
TMC125 Combined With Other
Antiretroviral Drugs.
A Simplification Study of Unboosted
Reyataz With Epzicom (ASSURE)
VIIV Healthcare
Pfizer CT.gov Call Center
Recruiting: Jacksonville, Miami,
St. Petersburg, Tampa
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID)
Sharon A. Nachman, MD, State
University of New York at
Stony Brook, Health Science
Center;
Andrew Wiznia, MD, Jacobi
Medical Center, Albert Einstein
College of Medicine
Study Director, Tibotec
Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical
Limited and IREL
GSK Clinical Trials and VIIV
Healthcare
To determine the safety and tolerability of maraviroc in HIV-infected children
and adolescents.; To determine the pharmacokinetic profile(s) and dosing
schedule(s) for maraviroc in treatment experienced HIV-infected children
and adolescents on different background therapies;; Describe the efficacy of
multiple dose administration of maraviroc in treatment experienced children
infected with CCR5 tropic HIV-1;; Describe tropism changes over time.
Termination from treatment due to suspected drug reaction attributable to
the study
medication; Grade 3 or 4 adverse events; Pharmacokinetic parameters; HI
V viral load; CD4 count and percentage;
Genotypic and phenotypic resistance measures
Recruiting: Jacksonville, Miami, Ft. Lauderdale, Tampa
The purpose of this study is to provide early access of TMC125 to HIV-1
infected patients who have failed multiple antiretroviral (ARV) regimens.
Information on safety and tolerability aspects of TMC125 in combination
with other ARVs in treatment-experienced HIV-1 patients with limited
treatment options will be assessed. Available data regarding the
effectiveness of the drug will also be collected. To be eligible, patients should
be failing their current ARV regimen or be on a treatment interruption,
should have previously received 2 different protease inhibitor (PI) containing
regimens and be at least 3-class experienced (protease inhibitors [PI],
nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and nonnucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class
experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will
be administered in combination with an investigator-selected background of
additional ARVs from the list of allowed medications.
To determine the proportion of subjects who maintain HIV-1 RNA <50
copies/mL through Week 24; Number of patients with adverse events as a
measure of safety and tolerability in each treatment arm; To assess change
from baseline in HIV-1 RNA and CD4+ cell count in each arm; To compare
change from baseline in fasting lipid parameters (triglycerides, total
cholesterol, LDL- and HDL-cholesterol)
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STUDY CATEGORY
CLINICAL TRIAL
PROJECT TITLE
Pharmacokinetic Study of Anti-HIV
Drugs During Pregnancy
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
Study to Evaluate Switching From
Regimens Consisting of Ritonavirboosted Protease Inhibitor (PI) and
Two Nucleoside Reverse Transcriptase
Inhibitors (NRTIs) to a Fixed Dose
Tablet Containing
Emtricitabine/Rilpivirine/Tenofovir DF
Pregabalin Versus Placebo In The
Treatment Of Neuropathic Pain
Associated With HIV Neuropathy
An Open-Label, Extension Safety Trial
Of Pregabalin In Subjects With
Neuropathic Pain Associated With
HIV Neuropathy (Pregabalin
A0081251)
A Randomized, Double-blind Study of
the Safety and Efficacy of
GSK1349572 50 mg Once Daily Versus
Raltegravir 400 mg Twice Daily, Both
Administered With an Investigatorselected Background Regimen Over
48 Weeks in HIV-1 Infected, Integrase
Inhibitor-Naïve, AntiretroviralExperienced Adults
High Dose Chemotherapy With
Autologous Stem Cell Rescue for
Aggressive B Cell Lymphoma and
Hodgkin Lymphoma in HIV-infected
Patients (BMT CTN 0803)
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID); EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH
AND HUMAN DEVELOPMENT
(NICHD)
Mark Mirochnick, MD, Boston
Medical Center
John Flaherty, PharmD, Gilead
Sciences
The purpose of this study is to determine what doses of anti-HIV medications
are appropriate for pregnant women.
Anti-HIV medication taken during pregnancy may control a woman's viral
load and reduce the chance that the baby will become infected with HIV.
Pregnant women may require different doses of anti-HIV drugs than women
who are not pregnant. This study will use pharmacokinetic (PK) sampling to
determine what doses of anti-HIV medications are best for HIV-infected
pregnant women and their infants.
Pfizer CT.gov Call Center
The purpose of this study is to evaluate the efficacy of pregabalin compared
to placebo in reducing neuropathic pain associated with HIV neuropathy.
Pfizer CT.gov Call Center
This study examines the safety of pregabalin over a 6 month period in
patients with neuropathic pain associated with HIV infection as an extension
of another trial that tests the efficacy of pregabalin.
Sherene Min, Project Physician
Lead GSK Clinical Trials
SHIONOGI
VIIV HEALTHCARE
ING111762 is a 48 week, randomized, double-blind, active-controlled,
multicenter, parallel group, non-inferiority study. The study will be
conducted in at least 688 HIV-1 infected antiretroviral experienced,
integrase-naïve subjects. Subjects will be randomized 1:1 to receive
GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each
added to an investigator selected background regimen consisting of at least
one fully active agent plus no more than one second single agent which may
or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and
development of viral resistance will be evaluated
This study is a Phase II, multicenter trial assessing overall survival after
autologous hematopoietic stem cell transplantation using a BEAM transplant
regimen in lymphoma patients with HIV.
Joseph Alvarnas, MD, City of
Hope National Medical Center
Richard Ambinder, MD, Johns
Hopkins Medical Institution
NATIONAL HEART, LUNG, AND
BLOOD INSTITUTE (NHLBI); N
ATIONAL CANCER INSTITUTE (N
The purpose of this study is to evaluate the non-inferiority of FTC/RPV/TDF
fixed dose regimen (FDR) relative to regimens consisting of a ritonavirboosted protease inhibitor (PI/r)and two nucleoside reverse transcriptase
inhibitors (NRTIs). The FDR could offer an attractive treatment option to
patients who wish to simplify dosing by reducing pill burden or to improve
the tolerability of their treatment.
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STUDY CATEGORY
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
Perinatal Core Protocol
(Prenatal and Postnatal Studies of
Interventions for Prevention of
Mother-To-Child Transmission)
Emergency Use Program for Highly
Treatment-Experienced HIV+ Patients
(Emergency Use Program for HTE
HIV+ Patients Who Need Tipranavir
Treatment)
Connect To Protect® Partnerships for
Youth Prevention Interventions: Phase
III
INVESTIGATORS
CI); BLOOD AND MARROW
TRANSPLANT CLINICAL TRIALS
NETWORK
Ruth Tuomala, MD,
Director of Obstetrics and
Gynecology, Brigham and
Women's Hospital; Gwen
Scott, MD, Pediatric Infectious
Diseases, University of Miami
School of Medicine
INTERNATIONAL MATERNAL
PEDIATRIC ADOLESCENT AIDS
CLINICAL TRIALS
GROUP; NAT’L INST. OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID); EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH
AND HUMAN DEVELOPMENT
(NICHD)
Boehringer Ingelheim
Pharmaceuticals
EUNICE KENNEDY SHRIVER
NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN
DEVELOPMENT
(NICHD); NATIONAL INSTITUT
E ON
DRUG ABUSE (NIDA); NATION
AL INSTITUTE OF
MENTAL HEALTH (NIMH); NAT
IONAL INSTITUTE ON ALCOHOL
ABUSE AND ALCOHOLISM
(NIAAA)
Jonathan Ellen, MD,Johns
Hopkins University Hospital
DEPARTMENT
SCIENTIFIC AREA
The purpose of this study is to collect and study clinical and laboratory
information about a pregnant or new mother and her medical care that will
increase our knowledge of the best care for HIV-infected pregnant women
and their children.
The rate of transmission of HIV from mothers to their infants has gone down.
Specific U.S. Public Health Service guidelines recommend that HIV-infected
pregnant women be treated with anti-HIV therapies; but the effectiveness of
treatment and safety for the mother and her infant have not been fully
examined. This study will monitor the health of women and their infants
while they receive anti-HIV therapy. Also, this study will provide information
that may be used for future studies.
To provide early access to tipranavir and evaluate the safety and tolerance of
tipranavir combined with low dose of ritonavir in patients with progressive,
HIV-1 disease who have failed or are intolerant to currently approved
treatments for HIV infection, who are unable to participate in another
tipranavir controlled clinical trial and have an urgent need for anti-HIV
treatment.
Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is
a multi-site, three-phase project developed by the Adolescent Medicine
Trials Network for HIV/AIDS Interventions (ATN). The overall goal of the
project is to ultimately reduce HIV incidence and prevalence in youth 12-24
years old through a community mobilization intervention. This protocol (ATN
040) describes part one of Phase III. Part two of Phase III will be submitted as
a separate protocol (ATN 041).
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
PROJECT TITLE
A Phase 1/2, Open Label, Single
Infusion Study of Autologous T-Cells
Genetically Modified at the CCR5
Gene by Zinc Finger Nucleases (SB728-T) in HIV Infected Subjects
NCT01252641
A Phase 2B Open Label Pilot Study to
Evaluate Switching From a Regimen
Consisting of a
Efavirenz/Emtricitabine/Tenofovir
Disoproxil Fumarate (EFV/FTC/TDF)
Single Tablet Regimen (STR) to
Emtricitabine/Rilpivirine/Tenofovir
Disoproxil Fumarate (FTC/RPV/TDF)
STR in Virologically Suppressed, HIV 1
Infected Subjects
NCT01286740
Pilot Assessment of
Lopinavir/Ritonavir and Maraviroc in
Experienced Patients
NCT00981318
Intensive Pharmacokinetic Studies of
New Classes of Antiretroviral Drug
Combinations in Children, Adolescents
and Young Adults
NCT00977756
INVESTIGATORS
SANGAMO Biosciences
Winson Tang, M.D., Sangamo
BioSciences, Inc.
Alena Jandourek, MD,
Gilead Sciences
DEPARTMENT
SCIENTIFIC AREA
This research study is being carried out to study a new way to possibly treat
human immunodeficiency virus (HIV). The agent is called SB-728-T which are
CD4+ T-cells obtained from an individual that are genetically modified at the
CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain
types of HIV to enter into and infect T-cells. T cells are one of the white blood
cells used by the body to fight HIV. The most important of these are called
"CD4+ T-cells"
Some people are born without the CCR5 gene on their T-Cells. These people
remain healthy and are resistant to infection with HIV. Other people have a
low number of CCR5 genes on their T-cells and their HIV disease is less
severe and is slower to cause disease (AIDS). The purpose of this research
study is to find out whether SB-728-T is safe to give to humans and find out
how this affects HIV.
The purpose of this pilot study is to evaluate the efficacy and safety of
FTC/RPV/TDF STR after switching from EFV/FTC/TDF at baseline in
maintaining HIV-1 RNA < 50 copies/mL at week 12. HIV-infected patients who
have been receiving EFV/FTC/TDF for greater than or equal to 3 months and
are experiencing safety or tolerability concerns (in particular, efavirenzrelated intolerance) may wish to change to an alternate, better tolerated
regimen.
Abbott,
Barry M. Rodwick, M. D.
This is a study to assess the response of lopinavir/ritonavir plus maraviroc
(with no nucleoside medications) in HIV patients failing their initial antiviral
therapy.
Jennifer R. King, Pharm. D.,
U of A at Birmingham;
Ram Yogev, MD,
Northwestern University
Feinberg School of Medicine
INTERNATIONAL MATERNAL
PEDIATRIC ADOLESCENT AIDS
CLINICAL TRIALS GROUP
NATIONAL INSTITUTE OF
ALLERGY
AND INFECTIOUS DISEASES
This study will examine drug and body interactions in children receiving antiHIV treatment regimens using new medications. Drug regimens to be
examined will feature the medications raltegravir (RAL), maraviroc (MVC),
and etravirine (ETV). These drugs will not be provided through the study.
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
(NIAID)
CLINICAL TRIAL
A Multicenter, Single Arm, Open-Label
Study of the Once Daily Combination
of Etravirine and Darunavir/Ritonavir
As Dual Therapy in Early TreatmentExperienced Patients
Tibotec, Inc. Clinical Trial
NCT01199939
A 12-Week, Randomized, DoubleBlind, Active-Controlled, ParallelGroup Study Comparing Pitavastatin
4 mg vs. Pravastatin 40 mg in HIVInfected Subjects With Dyslipidemia,
Followed by a 40-Week Safety
Extension Study
NCT01301066
Safety and Immunogenicity of
GlaxoSmithKline Biologicals' Herpes
Zoster Vaccine 1437173A in Adult
HIV-infected Subjects
NCT01165203
KOWA RESEARCH INSTITUTE,
INC.
Roger E Morgan, MD, FACS
BEHAVIORAL/EPIDEMIOLOGICAL
Maraviroc Plus Darunavir/Ritonavir
Study for Treatment-Naïve Patients
Infected With R5-tropic HIV-1 Based
on Enhanced Sensitivity Trofile
NCT00993148
Principal Investigator: Jose
Castro, M.D. (U of Miami);
Babafemi Taiwo, MD,
Northwestern University
PFIZER
TIBOTEC, INC
CLINICAL TRIAL
An Observer- and Subject-Blinded,
Randomized, Placebo-Controlled,
GSK Investigational Site, Daytona
Beach, Florida
CLINICAL TRIAL
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
GSK Clinical Trials
877-379-3718
GSKClinicalSupportHD@gsk.co
m
877-379-3718
This study is a Phase II single arm, open-label, multicenter, study of 50
human immunodeficiency virus-1 (HIV) infected adult patients, all of whom
will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally
once daily. This trial is designed to evaluate the efficacy of the
aforementioned ARV regimen, as measured by the percentage of patients
with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced
HIV-infected patients. In addition to general safety parameter
measurements, this trial will also assess changes in metabolic, inflammatory,
immune restoration, and bone markers. Screening will occur over a 6-week
period. The primary endpoint will be assessed at Week 48, and the treatment
period is 48 weeks. The end of study endpoint will be met by either
completing the Week 48 visit, or by early termination from the study for any
reason.
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group
Study.
This observer-blind study will evaluate the safety and immunogenicity of
GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine
GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects,
firstly enrolling subjects treated with antiretroviral therapy (ART) and with
high CD4 T cell counts, and subsequently ART-treated subjects with low CD4
T cell counts, and ART-naïve subjects with high CD4 T cell counts. This
Protocol Posting has been updated following Amendment 1 of the Protocol,
August 2010. The impacted section is exclusion criteria.
The objective of this study is to evaluate the safety and efficacy of a novel
combination antiretroviral therapy regimen consisting of maraviroc plus
darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1.
The hypothesis is that in treatment-naive subjects infected with R5-tropic
HIV-1, combination antiretroviral therapy with maraviroc plus
darunavir/ritonavir is well tolerated and efficacious.
A single dose escalation study to determine the safety, tolerability, and
pharmacokinetic profile of intramuscular and subcutaneous injections of
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STUDY CATEGORY
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
CLINICAL TRIAL
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Single Dose Escalation Study to
Investigate the Safety, Tolerability
and Pharmacokinetics of
Intramuscular and Subcutaneous
Long Acting GSK1265744 in Healthy
Subjects
NCT01215006
A Phase II Trial of Response-Adapted
Therapy of Stage III-IV Hodgkin
Lymphoma Using Early Interim FDGPET Imaging
VIIV Healthcare – Study Sponsor
GSK1265744 long acting parenteral (LAP) in healthy subjects. This study
consists of a screening visit, a single injection, and follow-up evaluations for a
minimum of 12 weeks following the injection.
M.D. Anderson Canter Center at
Orlando
Recruiting
Orlando, FL
NCT00822120
Contact: Julio J. Hajdenberg,
M.D.
321-841-7219
Southwest Oncology Group
National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill
more cancer cells. G-CSF may help lessen the side effects in patients
receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18PET/CT imaging, may help doctors predict how patients will respond to
treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging
to see how well it works in assessing response to combination chemotherapy
and allow doctors to plan better additional further treatment in treating
patients with stage III or stage IV Hodgkin lymphoma.
A Randomized, Double Blind, PlaceboControlled, Parallel-Group,
Multicenter Trial of An Investigational
Medication VS. Placebo in The
Treatment of Neuropathic Pain
Associated With HIV Neuropathy
Email:
cahlstrom@southfloridamedicalr
esearch.com
Cheryl Ahlstrom, Patient
Liaison/Recruitment
South Florida Medical Research
21150 Biscayne Blvd , Suite 300
Aventura, FL 33180
Phone: 305-931-8080
Fax: 305-931-8088
The study is being done to find out the good and bad effects of an
investigational drug that is not approved for sale to treat peripheral
neuropathic pain associated with HIV. The purpose is to see if the study drug
relieves peripheral neuropathic pain associated with HIV. The study will also
evaluate any side effects and whether or not they might be related to the
study drug. Lastly, the study will assess whether patients will experience
improvement in sleep , general health, and on symptoms of anxiety and
depression. There will be about 422 people in this study. You will be in the
study for about 127 days.
HIV-Neuropathy Study- Phase three
trial which lasts for 5 months with 12
visits for patients who suffer from
neuropathic pain associated with HIV.
Phase 3B, randomized, double-blind,
placebo-controlled, parallel group,
study of drug vs. a placebo in the
treatment of neuropathic pain
associated with HIV-1 infection. It is a
5 month, 12 visit study to compare
the effects of the study medication to
Email:cahlstrom@southfloridam
edicalresearch.com
Cheryl Ahlstrom, Patient Liaison
South Florida Medical Research
21150 Biscayne Blvd, Suite 300
Aventura, FL 33180
Phone: 305-931-8080
Fax: 305-931-8088
Men or women 18 years or older with documented evidence of HIV-1
infection who have distal symmetrical polyneuropathy with subjective
sensory symptom of pain. (physician rated)
Pain started in the feet
Must have moderate to severe neuropathy symptoms in the feet for at least
3 months due to HIV neuropathy
Pain is constant every day
HIV treatment is stable
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STUDY CATEGORY
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
PROJECT TITLE
placebo.
An International Observational Study
to Characterize Adults Who Are
Hospitalized With Complications of
Influenza A – Pandemic H1N1
(H1N1v); NCT01056185
INSIGHT H1N1v Outpatient Study
(FLU 002)
Official Title: An International
Observational Study to Characterize
Adults With Influenza A – Pandemic
H1N1 (H1N1v); NCT01056354
A Blinded, Randomized, Placebocontrolled, Dose Ranging Study to
Evaluate the Safety, Tolerability,
Pharmacokinetics, and Antiviral
Activity of Multiple Doses of ABT-450
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
UNIVERSITY OF MINNESOTA –
CLINICAL AND TRANSLATIONAL
SCIENCE INSTITUTE
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID)
NATIONAL INSTITUTES OF
HEALTH (NIH)
Infectious Diseases Associates
NW FL, PA
Pensacola, Florida, United
States, 32504
Contact: Barbara He Wade, MD,
FACP
850-476-3131
bwade@infectioncenter.com
Principal Investigator: Barbara
He Wade, MD, FACP
UNIVERSITY OF MINNESOTA CLINICAL AND TRANSLATIONAL
SCIENCE INSTITUTE;
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID)
NATIONAL INSTITUTES OF
HEALTH (NIH) Infectious Diseases
Associates NW FL, PA
Not yet recruiting
Pensacola, FL
P.I.: Barbara Wade, M.D.
Contact Barbara Wade, MD
850-476-3131
bwade@infectioncenter.com
The “flu” is a common disease and usually mild, but severe disease and death
may occur. There are several types of flu viruses and they change over time.
Recently, a new influenza A virus known commonly as swine flu or H1N1v
has emerged. This flu has spread rapidly around the world. It is important to
understand the course of illness for those who have H1N1v and the
characteristics of people who do not do well. The investigators will also try to
learn more about how different treatments and prior vaccination for the flu
affects the course of the illness. Approximately 1,000 individuals will be
enrolled in several countries around the world. The results of this study will
be used to advise on the management of patients who are hospitalized with
the flu.
ABBOTT Contact: Christian
Naylor
(847) 935-2492
christian.naylor@abbott.com
Contact: Victoria M Mullally
847-935-1406
A 12-week study of combination direct-acting antiviral agent (DAA) and
pegIFN/RBV in subjects with chronic HCV.
The "flu" is a common disease and usually mild but severe disease and
deaths may occur. There are several types of flu viruses and they change
over time. Recently, a new influenza A virus known commonly as swine flu or
H1N1v has emerged. This flu has spread rapidly around the world. It is
important to understand the course of illness for those who have H1N1v and
the characteristics of people who do not do well. The investigators will also
try to learn more about how different treatments and prior vaccination for
the flu affect the course of the illness. Approximately 5,000 individuals with
swine flu will be enrolled in several countries around the world.
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STUDY CATEGORY
CLINICAL TRIAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
PROJECT TITLE
With Ritonavir (ABT-450/r), ABT-333
or ABT-072 Each Administered Alone
and in Combination With
Peginterferon α-2a and Ribavirin
(PegIFN/RBV) in Treatment- Naïve
Subjects With Genotype 1 Chronic
Hepatitis C Virus (HCV) Infection
NCT01074008
A Study of Danoprevir Boosted With
Low Dose Ritonavir in Combination
With Pegasys and Copegus in
Treatment-Naive Patients With
Chronic Hepatitis C Virus Infection
NCT01220947
Isotretinoin With or Without
Monoclonal Antibody, Interleukin-2,
and Sargramostim Following Stem
Cell Transplantation in Treating
Patients With Neuroblastoma
Official Title: Phase III Randomized
Study Of Chimeric Antibody 14.18
(CH14.18) In High Risk
Neuroblastoma Following
Myeloablative Therapy And
Autologous Stem Cell Rescue
NCT00026312
Study on The Combination of
RO5024048 And Ritonavir-Boosted
Danoprevir With And Without
Copegus (Ribavirin) in InterferonNaïve Patients With Chronic Hepatitis
C Genotype 1 (INFORM-SVR)
Official Title: INFORM-SVR: A
Randomized, Multi-Center Study of
Interferon-Free Treatment With a
Combination of a Polymerase
Inhibitor (RO5024048) and a Ritonavir
Boosted HCV Protease Inhibitor
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
tori.mullally@abbott.com
Orlando area
HOFFMANN-LA ROCHE
Recruiting Orlando and South
Miami, FL
Study ID #: NV22776
888-662-6728 (U.S. only)
Genentechclinicaltrials@druginf
o.com
Numerous locations throughout
Florida
CHILDREN'S ONCOLOGYGROUP;
NATIONAL CANCER
INSTITUTE (NCI)
Under 30 yrs old
Study Chair:
Alice L. Yu, M.D., Ph.D.
UC at San Diego
HOFFMAN-LA ROCHE
Will be recruiting in Orlando, FL
Please reference Study
ID # PP25213
888-662-6728
genentechclinicaltrials@druginfo
.com
This randomized, open-label, active-controlled, parallel-group study will
evaluate the sustained virological response of danoprevir boosted with low
dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and
Copegus versus Pegasys and Copegus alone in treatment-naive patients with
chronic Hepatitis C
RATIONALE: Drugs used in chemotherapy work in different ways to stop
tumor cells from dividing so they stop growing or die. Monoclonal antibodies
can locate tumor cells and either kill them or deliver tumor-killing substances
to them without harming normal cells. Interleukin-2 and sargramostim may
stimulate a person's white blood cells to kill cancer cells. It is not yet known if
chemotherapy is more effective with or without monoclonal antibody
therapy, interleukin-2, and sargramostim following stem cell transplantation
in treating neuroblastoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of
chemotherapy with or without monoclonal antibody, interleukin-2, and
sargramostim following stem cell transplantation in treating patients who
have neuroblastoma
This multicenter, randomized, double-blind, parallel group study will
evaluate the safety and efficacy of the combination RO5024048 and
ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients
with chronic hepatitis C genotype 1 who are treatment-naïve for interferons.
Patients will receive 1000 mg RO5024048 orally twice daily and 100 mg
danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000
mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral
response, the assigned treatment will be continued for a further 12 weeks.
The anticipated time on study treatment is up to 24 weeks plus a 24-week
follow-up
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FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
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Page 42 of 84
STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
(RO5190591/r, DNV/r) With or
Without Copegus® in Interferon Naïve
HCV Genotype 1 Infected Patients
NCT01278134
COMMUNITY AIDS NETWORK, SARASOTA, FL
TANYA SCHREIBMAN, M.D., MEDICAL DIRECTOR
CLINICAL TRIAL
Title: A pilot randomized, open-label
study comparing the safety and
efficacy of a Raltegravir based NRTI
sparing regimens "No Nukes Study".
Site Investigator: Tanya
Schreibman, M.D. (PI is Yale
based: Michael Kozal, MD)
Community AIDS Network
941-366-0134
Study primary site is Yale
University with our site
(Community AIDS
Network/Comprehensive
Care Clinic) as a satellite site
HIV, antiretroviral therapy
ORLANDO IMMUNOLOGY CENTER, ORLANDO, FL
EDWIN DEJESUS, M.D., MEDICAL DIRECTOR
CLINICAL TRIAL
Title: Evolution of L74V or K65R
Mutations in Vlremic Subjects on TDF or
ABC (EVITA)
Study Director: Edwin
Dejesus, MD, FACP
(407) 647-3960
This is a multicenter, open-label, non-randomized, dual-arm pilot study
to investigate the prevalence of the reverse transcriptase (RT)
resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects
experiencing confirmed first-time incomplete virologic suppression
during treatment with an initial antiretroviral (ARV) regimen consisting
of at least 12 weeks of TDF or ABC + emtricitabine (FTC) or lamivudine
(3TC) + non-nucleoside reverse transcriptase inhibitor (NNRTI) or
protease inhibitor (PI). Subjects will be followed until a substantial loss
of virologic or immunologic control requires a treatment switch.
Confirmed first-time incomplete virologic suppression is defined as an
initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent
virologic rebound > 400 copies/mL measured at two consecutive times.
Subjects will have a screening genotype to establish adherence to their
non-suppressive TDF- or ABC-containing regimen by the presence of
M184V (or other treatment-related primary) mutation and to
demonstrate that the evolution of treatment-emergent RT mutations
can be characterized.
Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20
United States (U.S.) sites. If fewer than 20 subjects can be enrolled, the
study may be discontinued early by the sponsor. Equal numbers of
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Page 43 of 84
STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
subjects on Arm A versus Arm B will be a goal.
TOTAL NUMBER OF CLINICAL TRIAL STUDIES LISTED AS OF 9/12/11 = 161
Rev. 9/29/11
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
BEHAVIORAL/EPIDEMIOLOGICAL STUDIES
UNIVERSITY OF CENTRAL FLORIDA
Presenter: Alexander M. Cole, Ph.D.
BEHAVIORAL/EPIDEMIOLOGICAL
HIV Prevention for Criminal
Justice-involved Individuals
(grant through Nehemiah
Educational & Economic
Development, Inc.)
Roberto Potter, Ph.D.
Clinical Justice
HIV Prevention
NOVA SOUTHEASTERN UNIVERSITY – 4 Studies
Presenter: Isa Fernandez, Ph.D.
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
Cyber Mentors: A Sustainable
Model for Developing Minority
HIV Researchers
Maria Isabel Fernandez,
Ph.D. John Anderson,
Ph.D.
College of Osteopathic
Medicine
Mentoring and faculty development in HIV
prevention
Proyecto SOL: A Risk Reduction
Intervention for Hispanic MSM
Recently Completed
Maria Isabel Fernandez,
Ph.D.; G. Stephen Bowen,
M.D., M.P.H.
College of Osteopathic
Medicine
HIV prevention among Latino/Hispanic
MSM
Understanding the Scope and
Magnitude of Prescription Drug
Diversion
Steven P. Kurtz, Theodore
J. Cicero, Hilary L. Surratt
Division of Applied
Interdisciplinary Studies
HIV, drug use, diversion
National Institute on Drug Abuse Grant #
DA021330
The Diversion of Antiretroviral
Medications to Street Markets
Hilary L. Surratt, Gladys
Ibanez, Steven P. Kurtz
Division of Applied
Interdisciplinary Studies
HIV, diversion, ARV medications, drug use
National Institute on Drug Abuse Grant #
DA023157
FLORIDA STATE UNIVERSITY
Presenter: Neil Abell, Ph.D., L.C.S.W. – 11 Studies
BEHAVIORAL/EPIDEMIOLOGICAL
Promoting Male Involvement to
Improve Prevention of Motherto-Child Transmission Uptake
and Reduce Antenatal Infection
Deborah Jones (PI), Karl
Peltzer, Stephen Weiss, Olga
Villar.
Psychiatry Micro and
Immunol.
HIV and women.
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STUDY CATEGORY
INVESTIGATORS
DEPARTMENT
Expression and impact of
HIV/AIDS provider stigma in the
West Indies: Examining the
context of testing, treatment,
and care
Rutledge, S.E., and Abell, N.,
Padmore, J., & McCann, T.
HIV/AIDS Provider Stigma; International
Social work and HIV/AIDS in
Northern India
Abell, N., & Thomas, G., &
associates
Validation of the HIV/AIDS
Provider Stigma Inventory
(HAPSI)
Abell, N., Rutledge, S.E.,
Whyte, IV, J., Brown, K., &
Cesnales, N.
College of Social Work
and UNIVERSITY OF THE
WEST INDIES, ST.
AUGUSTINE, TRINIDAD
& TOBAGO; ST.
GEORGE’S UNIVERSITY,
GRENADA
College of Social Work
and
INDIRA GHANDI
NATIONAL OPEN
UNIVERSITY
College of Social Work,
College of Nursing and
TEMPLE UNIVERSITY
Awareness/Acceptance/Action
Model (AAAM): Mindfulness and
Stigma
Abell, N., & Rutledge, S.E.
College of Social Work
and TEMPLE
UNIVERSITY
HIV/AIDS provider stigma; Intervention
modeling
Assessing capacity for self-care
among HIV heads of household:
Bilingual validation of the
Parental Self-Care Scale
Bilingual validation of the Family
Responsibility Scale: Assessing
stress among HIV+ heads of
household
Development and evaluation of
the Adherence Attitudes
Inventory
Abell, N., Ryan, S., &
Kamata, A.
College of Social Work,
College of Education
Prevention; Intervention; Psychometrics
Abell, N., Ryan, S., &
Kamata, A.
College of Social Work,
College of Education
Prevention; Intervention; Psychometrics
Lewis, S., & Abell, N.
College of Social Work
Treatment; Psychometrics
BEHAVIORAL/EPIDEMIOLOGICAL
Assessing willingness to care for
persons with AIDS
Abell, N.
College of Social Work,
College of Education
Caregiving; Psychometrics
BEHAVIORAL/EPIDEMIOLOGICAL
Cultivating Compassion:
Recognizing and Interrupting
Abell, N., Garland, E.,
Whyte, IV, J., Eccles, D., &
College of Social Work
and TEMPLE
HIV/AIDS provider stigma; Intervention
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
SCIENTIFIC AREA
Prevention, education, & outreach;
International; Curriculum development
HIV/AIDS provider stigma; Psychometrics
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
Unconscious Stigmatizing
Responses in HIV/AIDS Health
Care and Social Service Provision
(Proposed)
Health Relationships for Women
with HIV
DEPARTMENT
Rutledge, S.E.
UNIVERSITY
Stephanie Marhefka, Robert
Gleukhauf
FSU College of Medicine
and DPH, Medical
Humanities and Social
Science
SCIENTIFIC AREA
Behavioral intervention for women with
HIV
UNIVERSITY OF MIAMI – 29 Studies
Presenter: Savita Pahwa, M.D.
BEHAVIORAL/EPIDEMIOLOGICAL
BASIC SCIENCE/VIROLOGY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
Longitudinal analysis of a high
risk HIV negative cohort
The impact of early
antiretroviral therapy on HIV
persistence and inflammation
Promoting Male Involvement to
Improve Prevention of MotherTo-Child Transmission Uptake
and Reduce Antenatal Infection
Implementing HIV Risk
Reduction Zambia
Derek Dykxhoorn (Human
Genetics, Microbiology and
Immunology, DCFAR), Lisa
Metsch (Epidemiology and
Public Health, DCFAR), Jose
Castro (Medicine, DCFAR),
Savita Pahwa
(Microbiology and
Immunology, DCFAR),
Margaret Fischl (Medicine,
DCFAR), Rafick Sekaly
(VGTI-Florida, DCFAR),
Lydie Trautmann (VGTI-FL,
DCFAR)
Mario Stevenson, Stevens
Deeks UCSF (PI)
Human Genetics,
Microbiology and
Immunology,
Epidemiology and Public
Health, Medicine, VGTIFL, Developmental
Center for AIDS
Research (DCFAR)
Genetics and Genomics of HIV infection,
Acute HIV infection (AHI)
Medicine
To evaluate whether early intervention
can improve treatment responses in HIV
infected individuals.
Deborah Jones,
Karl Peltzer,
Stephen Weiss,
Olga Villar
Deborah L. Jones Weiss
Psychiatry
Micro and Immunology
HIV and women Sponsor: PEPFAR
Psychiatry & Behavioral
Sciences
NICHD
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Enhancing HIV Medication
Adherence in India
Deborah L. Jones Weiss
Psychiatry & Behavioral
Sciences
NINR
Longitudinal Dyadic Analysis of
HIV-positive Substance Users
with Trauma History
Deborah Jones Weiss
Psychiatry & Behavioral
Sciences
NIDA
Juvenile Offender HIV
Prevention and Drug Abuse
Services
Howard Liddle
Epidemiology & Pub.
Health Med.
NIDA
Center for Implementing
Juvenile Justice Drug Abuse &
HIV Systems Interventions
Howard Liddle
Epidemiology & Pub.
Health Med.
NIDA
HIV Testing and Counseling in
STD Clinics: an Adaptation of
CTN 0032
Lisa R. Metsch
Epidemiology & Pub.
Health Med.
NIDA
BEHAVIORAL/EPIDEMIOLOGICAL
HIV Testing in Dental Care
Settings
Lisa R. Metsch
Epidemiology & Pub.
Health Med.
NIDCR
BEHAVIORAL/EPIDEMIOLOGICAL
Enhancing Oral Health Care Use
by HIV-Positives
Lisa R. Metsch
Epidemiology & Pub.
Health Med.
NIDCR
BEHAVIORAL/EPIDEMIOLOGICAL
Prevention Among HIV+ Crack
Users in the Hospital
Lisa R. Metsch
Epidemiology & Pub.
Health Med.
NIDA
Familias Unidas State III Study:
Preventing Substance Abuse in
Hispanic Youth
Guillermo Prado
Epidemiology & Pub.
Health Med.
NIDA
Preventing Drug Abuse & HIV in
Hispanic First Offenders
Guillermo Prado
Epidemiology & Pub.
Health Med.
NIDA
PS07-003, Minority HIV/AIDS
Guillermo Prado
Epidemiology & Pub.
OTHER
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
Research Initiative (MARI)
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
DEPARTMENT
SCIENTIFIC AREA
Health Med.
Long-term Outcomes and
Economic Impact of the
Detention to Community Model
Cynthia Rowe
Epidemiology & Pub.
Health Med.
NIDA
The Role of Culture in Thriving
and Risk Behavior in Hispanic
Adolescents
Seth J. Schwartz
Epidemiology & Pub.
Health Med.
NIDA
Sex and gender influences on
addiction and health
Bandstra, E.
Drug Abuse
NIDA
Family intervention for teen
drinking and alcohol-related
crises in the ER
Rowe, C.
Drug Abuse
NIAAA
Culturally informed family based
treatment of adolescents: A
randomized trial
Santisteban, D.
Drug Abuse
NIDA
Identity and context in HIV
prevention for Hispanic youth
Schwartz, S.
Drug Abuse
NIDA
Alcohol and HIV in Latin America
Shor-Posner, G.
Drug Abuse
NIAAA
Longitudinal Dyadic Analysis of
HIV-positive Substance Users
with Trauma History
Heath literacy, cognitive and
social determinants of HIV
appointment attendance
Deborah Jones
Behavioral Research
NIDA
Drenna Waldrop-Valverde
Behavioral Research
NIMH
A targeted decision and to
improve minority participation
in clinical trials
Margaret Byrne
Behavioral Research
NCMHD
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
HAART associated cardiotoxicity
in HIV-infected children
PHACS (Pediatric HIV/AIDS
Cohort Study)
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
CTN 0049: Project HOPE:
Hospital Visit is an Opportunity
for Prevention and Engagement
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Steven Lipshultz
Pediatric Metabolic/
Pathogenesis Research
NHLBI
Gwendolyn Scott
Pediatric Metabolic/
Pathogenesis Research
NICHD
Lisa Metsch, PI
NIDA Clinical Trials
Network (CTN)
CTN 0047: SMART ED SBIRT* in
the Emergency Dept. *screening,
brief interventions, referral and
treatment
NIDA Clinical Trials
Network (CTN)
DUVAL COUNTY HEALTH DEPARTMENT
Presenter: M. Maximillion Wilson, Ph.D. – 2 Studies
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
The Interdiction Project
HIV Mapping: Understanding
Service Gaps through use of GIS
M. Maximillion Wilson,
Ph.D. (PI), Samuel
Frimpong, M.D., M.P.H.
(co-PI)
M. Maximillion Wilson,
Ph.D. (PI), David L.
Andress
Prevention Unit, Area 4
AIDS Program Office
Behavioral Intervention, Prevention-forPositives
Prevention Unit, Area 4
AIDS Program Office.
Public Health Program Evaluation
UNIVERSITY OF SOUTH FLORIDA – 17 Studies
Presenter: John W. Sleasman, M.D.
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
Novel dissemination of a group
intervention for HIV+ women via
web conferencing
Marhefka, Stephanie (PI)
Baldwin, Julie
Buhi, Eric
Community and Family
Health
Florida/Carribean AIDS
Education and Training Center
Jeff Beal
Mental Health Law &
Policy
Behavioral Science, HIV+ Women,
Prevention, MTCT
Intervention Dissemination
Sponsor: NIMH
Provider training, Educational materials
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STUDY CATEGORY
PROJECT TITLE
BEHAVIORAL/EPIDEMIOLOGICAL
Perinatal HIV Transmission
Prevention Project
Michael Knox (PI)
Mental Health Law &
Policy
Provider training, Educational materials
Environmental Factors in HIV
Transmission Among Suburban
IDUs
Wilson Palacios (PI)
Criminology
Prevention, IVDU
A Randomized Controlled Trial of
Family-Based HIV Prevention for
Latino Youth
Celia Lescano (PI)
Mental Health Law &
Policy
prevention intervention, Latinos,
disparities
BEHAVIORAL/EPIDEMIOLOGICAL
Evaluation of Pinellas County
Adult Treatment Drug Court
Kathleen Moore (PI)
BEHAVIORAL/EPIDEMIOLOGICAL
Medication Assisted Drug Court
Treatment (MADCT) Program
Kathleen Moore (PI)
New Faculty Recruitment to
Enhance Co-Morbidity Research
in Justice Settings
Roger Peters (PI)
Conference: Advances in
Translational Research in
AIDS/HIV in India
Shyam Mohapatra (PI)
Internal Medicine
basic and translational research in HIV;
collaborative projects
ATN 096: Identifying
Undiagnosed Asymptomatic HIV
Infection in Hispanic/Latino
Adolescents and Young Adults
Program in Adolescent HIV/AIDS
Research Training (PAHRT) –
Fogarty AITRP
Diane Straub and Patricia
Emmanuel
Pediatrics
HIV testing, linkage to care, Latino
Patricia Emmanuel (PI)
Pediatrics
prevention, treatment and natural history
studies in Gujurat India
Ryan White Care Act Title IV
Adolescent Initiative
PATRICIA EMMANUEL (PI)
PEDIATRICS
HIV TESTING, OUTREACH AND CARE FOR
YOUTH
Brief Intervention for Drug Use
Richard Dembo (PI)
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Prevention; Drug Use
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
and HIV/STD Risk Prevention
Among Truants
Statistical Methods for LongTerm HIV Dynamic Modeling
and Design
INVESTIGATORS
Brian Giunta (PI)
Statistical Methods for LongTerm HIV Dynamic Modeling
and Design
Yangxin Huang (PI)
BEHAVIORAL/EPIDEMIOLOGICAL
A Randomized Controlled Trial of
Family-Based HIV Prevention
Celia Lescano (PI)
BEHAVIORAL/EPIDEMIOLOGICAL
Enhancing NIH Supported health
Research in Gujurat, India
Tiffany Ann Chenneville
(PI)
BEHAVIORAL/EPIDEMIOLOGICAL
DEPARTMENT
SCIENTIFIC AREA
Psychiatry and
Neurosciences
Pediatrics
ORANGE COUNTY HEALTH DEPARTMENT – 2 Studies
Presenter: Gerald Horton, Jr. M.D.
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
SiHLE A study seeking to
determine the effectiveness of
the SIHLE model to reduce
sexual health and relationshiprelated disparities in the Orange
County zip codes: 32808, 32811,
3281 and increase self-efficacy,
self-esteem, communication and
condom negotiation skills in
females, ages 14 -18 years.
(PD)- Karen Wint, MPA
Ronessa StricklandRoberts, MPH (Project
Coord)
Multimedia WILLOW Program
Outcome Study: A study to test
the effectiveness of a
multimedia version of a
HIV/AIDS Prevention Program
Archive (HAPPA) program and
Dr. Carmela Lomonaco
(PD) and Alelia Munroe,
MPH (Sub-PD, OCHD)
Immunology Clinics
HIV Behavioral Intervention and
Awareness African American Female,
Age18-50
SPONSOR: NIH, and SOCIOMETRICS Corp.
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
provide clients with additional
HIV management tools and
techniques.
UNIVERSITY OF FLORIDA
Presenter: Maureen Goodenow, Ph.D. - 8 studies
Anna Giuliano (PI) Moffitt
Cancer Center, Maureen
Goodenow (Co-PI), Li, Yin
(Co-I)
Thomas Clanton (PI)
Pathology
HPV in a multinational cohort of men
Exercise and Sports
Sciences
Pathogenesis
A breath-based medication
adherence monitoring system for
HIV-AIDS therapies (specific
AIM2-Food Interference)
Multiple behavior SBIRT Model of
drug abuse among emerging
adults in primary
Timothy Morey (PI), Donn
M. Dennis (Co-PI), Susan P.
McGorray (PI)
Anesthesiology Health
Outcomes and Policy
Adherence
Dennis Thombs (PI)
Behavioral Science and
Comm Health
Drug Abuse
Florida AIDS Education Training
Centers
Robert M. Lawrence (PI),
Charles E. Stewart (CO-PI)
Pediatrics
Education
HIV risk among racially-diverse,
minority youth and partner
selection
Stephanie Staras (PI)
Medicine
Behavior
BEHAVIORAL/EPIDEMIOLOGICAL
Pharmacotherapy for Hazardous
Drinking in HIV-infected women
Molecular epidemiology of HIV
infection in Morocco
Epidemiology,
Medicine, Peds, Social
& Behavioral Health
Sciences
Epidemiology
Pathology Geography
Alcohol and HIV Randomized clinical trial
BEHAVIORAL/EPIDEMIOLOGICAL
Robert L. Cook (PI), Bridgett
Rahim-Williams, Mobeen
Rathore, WHAT-IF study
investigators
Robert L. Cook (PI), Marco
Salemi, Andy Tatem,
Maureen Goodenow, Glenn
Morris, Moroccan Co-
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
Natural History of HPV Infection
in Men (HIM) Study
Smoking cessation and the
natural history of HIV-Induced
Emphysema
Contextual and behavioral factors
associated with HIV spread
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Investigators
FLORIDA INTERNATIONAL UNIVERSITY – 35 Studies
Presenter: Mario De La Rosa, Ph.D.
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
The Impact of HIV/AIDS among
Latina/o Suicide Victims
(completed)
Dr. Ramiro Martinez (PI)
School of Criminology
HIV/AIDS and Latina/o Suicide Victims
Funding Source: NIMHD
HIV and Substance Abuse Risk
Behaviors Among Hispanic Youth
of Florida (completed)
Dr. WayWay M. Hlaing
(PI)
School of Social Work
HIV, Substance Abuse, Risk Behaviors, and
Hispanic Youth of Florida
Funding Source: NIMHD
Impact of 2005 Hurricane Season
on HIV/ AIDS Health Services in
Miami Dade County (Completed)
Dr. Sukumar Ganapati
School of Social Work
2005 Hurricane Season, HIV/ AIDS, and
Health Services in Miami Dade County
Funding Source: NIMHD
Latino Minority Drug Abuse
Research Center: Women Study
(Completed)
Dr. Mario De La Rosa (PI),
Dr. Patria Rojas
School of Social Work
HIV Infection and Risk of Fatal
Drug Overdose in Miami
Communities: An Individual and
Community Level Analysis
(Completed)
Clusters and Trends of Sexual,
Substance Use, and Other Health
Risks among Hispanic and NonHispanic Adolescents (Completed)
HIV Risk Reduction In High Risk
Hispanic Migrant Workers In
South Florida (Completed)
Dr. Ramiro Martinez
CRUSADA
intergenerational transmission of drug
use, Risky sexual behaviors, Latino women
(mother-daughter dyads
Funding Source: NIDA
HIV Infection, Risk of Fatal Drug Overdose
in Miami Communities
Funding Source: NIMHD
WayWay Hlaing, Sunny
Kim, Mario De La Rosa
CRUSADA
Dr. Jesus Sanchez
CRUSADA
HIV Risk Behavior and Substance
Abuse among Recent Latino
Immigrants (ongoing)
Mario De La Rosa (PI),
Patria Rojas
CRUSADA
Clusters and Trends of Sexual, Substance
Use, and Other Health Risks and Hispanic
and Non-Hispanic Adolescents
Funding Source: NIMHD
HIV Risk Reduction and Risk Hispanic
Migrant Workers In South Florida Funding
Source: NIMHD
HIV Risk Behavior and Substance Abuse,
recent Latino Immigrants Funding Source:
NIMHD
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
A Longitudinal Study of Substance
Abuse and HIV Risk Among
Adult Latina Mother-Daughter
(ongoing)
Retrospective cohort study to
estimate the contribution of
socioeconomic status, segregation
and rural residence on racial
disparities in HIV survival, Florida
Mario De La Rosa (PI),
Patria Rojas, Frank Dillon
CRUSADA
Mary Jo Trepka (PI),
Theophile Niyonsenga,
Spencer Lieb, Lorene
Maddox
Epidemiology and
Biostatistics (and FDOH)
Trajectories
of Drug
Abuse and
Mario
De LaGanapati
Rosa (PI),
Impact of 2005
Hurricane
Dr.
Sukumar
HIV
Risk among
Father-Son Frank Dillon, Patria Rojas
Season
on HIV/Latino
AIDS Health
Dyads
(Planned)
Services
in Miami Dade County
(Completed)
Serotonin and Brain Derived
Investigators: Maria Jose
Neurotrophic Factor Roles on HIV
Miguez (PI), Mario De La
Risk Behaviors on Latino MotherRosa, Robert Malow,
Adolescent Dyads (Planned)
Patria Rojas, Changwon
Yoo
Alcohol Use and the ImmuneMaria Jose Miguez (PI),
Cardiovascular-Brain Loop in HIV
Deshratan Asthana,
Positives (Planned)
Ximena Burbano, Mario
De La Rosa, Mehmet
Dorak
Development of an Intervention
Robert Malow (PI), Maria
Package to Reduce Alcohol and
Jose Miguez, Jessy
DEPARTMENT
CRUSADA
School
of Social
Work
SCIENTIFIC AREA
Substance use, HIV risk behavior
trajectories, Latina mothers and daughters
Funding Source: NINR
To estimate the effect of community-level
deprivation and rural residence on racial
disparities in HIV survival over time
To estimate the effect of racial segregation
on HIV survival
To characterize changes in communitylevel socioeconomic status between the
time of AIDS diagnosis and death
To compare the degree of community
racial segregation between the time of
AIDS diagnosis and death
To characterize patterns and predictors of
rural to urban migration between AIDS
diagnosis and death
Funded by The NCMHHD
health
2005Substance
Hurricane abuse,
Season,HIV/AIDS,
HIV/ AIDS,
and Health
disparities,
Funding Source:
Services
in MiamiLatino
Dademen
County
NINR
Funding
Source: NIMHD
CRUSADA
Serotonin and Brain Derived Neurotrophic,
HIV Risk Behaviors, Latino MotherAdolescent Dyads
Funding Source: NINR
College of Public Health
Alcohol Use, Immune-Cardiovascular-Brain
Loop, HIV Positives
Funding Source: NIAAA
College of Public Health
Alcohol Use, Immune-Cardiovascular-Brain
Loop, HIV Positives
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
Sexual Risks (Planned)
Devieux
Multi-level HIV Prevention for
Pregnant Drug Abusers
Robert Malow (PI), Jessy
Devieux, Michele JeanGilles, Brenda Lerner,
Rhonda Rosenberg
Robert Stempel College
of Public Health and
Social Work
Intervening with HIV+ Alcohol
Abusers: Influence of NeuroBehavioral Factors
Robert Malow (PI), Jessy
Devieux, Michele JeanGilles, Brenda Lerner,
Rhonda Rosenberg,
Madhavan Nair
Robert Stempel College
of Public Health and
Social Work
Intervening with Haitian HIV+
Alcohol Abusers: An
environmental Psychosocial
Framework
Robert Malow (PI), Jessy
Devieux, Michele JeanGilles, Rhonda Rosenberg
Robert Stempel College
of Public Health and
Social Work
SCIENTIFIC AREA
Funding Source: NIAAA
This study of Pregnant Drug Abusers in
treatment is a randomized trial of
Enhanced- Behavioral Skills Training (EBST) compared to a time- and attentionmatched Health Promotion Comparison
(HPC) condition. It responds to the NIH
priority on translational research to adapt
effective research-based intervention
strategies to 'real world' conditions. If
successful, this research will offer a
realizable HIV intervention strategy,
bridging research and practice, that can be
implemented for pregnant drug abusers
within their communities.
Funded by NIDA
To reduce HIV sexual transmission risk and
substance use, increase the utilization of
primary HIV care services, and improve
psychosocial health among alcohol
abusing, HIV+ individuals. The study
evaluates memory, information
processing, executive functioning and
genetic factors of participants to discern
factors with treatment effects, and to
identify individual characteristics that may
contribute to specific reductions in risky
behaviors. Funded by NIAAA
To address the problem of health
disparities in HIV risks and to adapt
“effective” interventions to reach this
population in Haiti. The project also
responds to the NIH priority on bridging
clinical research and practice into
community settings in a manner adaptable
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
to “real world” conditions.
Funded by NIAAA
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
A longitudinal Study of Drug
Abuse & HIV Risk among Latina
Mother-Daughter Dyads
Mario De La Rosa (PI),
Patria Rojas, Frank Dillon
Robert Stempel College
of Public Health and
Social Work
HIV Risk Reduction in Migrant
Workers
H. Virginia McCoy, (PI);
Robert Malow, Co-PI;
Jessy G. Dévieux, CoInvestigator; Theophile
Niyonsenga, Biostatistician
Richard Beaulaurier (PI)
Robert Stempel College
of Public Health and
Social Work
Mario de la Rosa (PI),
Jesus Sanchez, Frank
Dillon, Robert Malow,
Changwon Yoo, Richard
Robert Stempel College
of Public Health and
Social Work
Curriculum Development Institute
Center for Substance Use and
AIDS Research on Latinos in the
United States (CRUSADA)
Robert Stempel College
of Public Health and
Social Work
To determine the influence of cultural and
social determinants on trajectories of
change for substance use and HIV risk
behaviors among a community-based
sample of Latina mothers and daughters.
To determine the influence of motherdaughter attachment on trajectories of
change for substance use and HIV risk
behaviors.
To determine the moderating role of
mother-daughter attachment on
associations between experiences of
detrimental social determinants and
trajectories of change for substance use
and HIV risk behaviors.
Funded by NINR
A randomized community trial to reduce
HIV risk and to promote healthy behaviors
among alcohol and other drug (AOD)-using
Migrant Workers
To explore the perspective of social
workers who treat or work with older
Latinos who are HIV+, including the
language, techniques and approaches
employed to discuss issues of sex,
sexuality and the risk of HIV infection with
their Latino patients and clients; Funded
by The John A. Hartford Foundation
To explore behavioral and social factors
contributing to or influencing minority
health and health disparities
To translate research findings into
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
Beaulaurier
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
Tanzanian Drug Treatment as
AIDS Prevention - Reliability and
Validity Study
Mark Williams (PI)
Robert Stempel College
of Public Health and
Social Work
HIV Risk Behavior and Substance
Abuse among Recent Latino
Immigrants
Community Mobilization for HIV
Prevention—Racial and Ethnic
Approaches to Community Health
(REACH) 2010 in Broward County.
Mario De La Rosa (PI),
Patria Rojas
Robert Stempel College
of Public Health and
Social Work
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
William W. Darrow, PI and
Project Leader
SCIENTIFIC AREA
interventions for improving minority
health or eliminating health disparities
To explore the efficacy of a range of health
promotion and information dissemination
approaches for improving minority health
or eliminating health disparities
To establish innovative partnerships
between academic and community
entities
To increase the number of researchers and
professionals committed to eliminate
health disparities
Funded by NCMHD: P-20 Center Grant
To develop culturally appropriate
measures of psychological functioning,
social functioning, treatment motivation,
addiction severity, and readiness for
treatment
To assess IDUs' understanding and
relevancy of the measures of psychological
functioning, social functioning, treatment
motivation, addiction severity, and
readiness for treatment
To test the reliability and validity of the DTAPP Questionnaire
Funded by NIDA
To study HIV Risk Behaviors and Substance
Abuse in recent Latino Immigrants
Funded by NCMHD
Eliminate disparities in HIV infection
among Black and Hispanic 18-39 year-old
residents of 12 high AIDS-prevalence ZIPcode areas of Broward County; Funded by
CDC
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
The Impact of HIV/AIDS among
Latina/o Suicide Victims
Dr. Ramiro Martinez (PI)
HIV and Substance Abuse Risk
Behaviors Among Hispanic Youth
of Florida
Dr. WayWay M. Hlaing
(PI)
Impact of 2005 Hurricane Season
on HIV/ AIDS Health Services in
Miami Dade County
Sukumar Ganapati
Latino Minority Drug Abuse
Research Center: Women Study
Mario De La Rosa (PI), Dr.
Patria Rojas
HIV Infection and Risk of Fatal
Drug Overdose in Miami
Communities: An Individual and
Community Level Analysis
Clusters and Trends of Sexual,
Substance Use, and Other Health
Risks among Hispanic and NonHispanic Adolescents
Ramiro Martinez (PI)
HIV Risk Reduction In High Risk
Hispanic Migrant Workers In
South Florida
Jesus Sanchez (PI)
Older Latina Perspectives on Sex,
Sexuality and Risk of AIDS
Richard L. Beaulaurier: PI
WayWay Hlaing, Sunny
Kim, Mario De La Rosa
DEPARTMENT
SCIENTIFIC AREA
School of Criminology
(Recently Completed
Studies)
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
HIV/AIDS and Latina/o Suicide Victims.
Funded by NCMHD
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
Robert Stempel College
of Public Health and
Social Work (Recently
Completed Studies)
HIV Risk Reduction and Risk Hispanic
Migrant Workers In South Florida. Funded
by NCMHD
HIV, Substance Abuse, Risk Behaviors, and
Hispanic Youth of Florida
Funded by NCMHD
2005 Hurricane Season, HIV/ AIDS, and
Health Services in Miami Dade County
Funded by NCMHD
Intergenerational transmission of drug
use, Risky sexual behaviors, Latino women
(mother-daughter dyads). Funded by
NIDA
HIV Infection, Risk of Fatal Drug Overdose
in Miami Communities. Funded by
NCMHD
Clusters and Trends of Sexual, Substance
Use, and Other Health Risks and Hispanic
and Non-Hispanic Adolescents Funded by
NCMHD
To document culturally-relevant
interpersonal and intrapsychic scripts
To classify respondents into discrete
groups based on behavioral indicators of
risk for HIV exposure. The study uses a
mixed methods design with qualitative
and quantitative components. Funding
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Agency: NIGMS
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
NIH NIAAA 3RO1AA017405-0251
MJM Gender Differences in an
HIV intervention
Míguez and Malow
Florida International
University
Research Core, C-SALUD: Center
for Substance Use and AIDS
Research on Latinos in the United
States
Robert Malow (Research
Core PI)
AIDS Prevention
Program, Department of
Health Promotion &
Disease Prevention and
Stempel College of Public
Health and Social Work
The main task of this study is to identify
gender differences in cognitive tasks and
genetic polymorphisms that can explain
differential responses to brief alcohol
interventions. The study evaluates
memory, information processing,
executive functioning and genetic factors
of participants to discern factors with
treatment effects, and to identify
individual characteristics that may
contribute to specific reductions in risky
behaviors
The Research Core is aimed at designing
and implementing long-term
infrastructure support to facilitate and
guide interdisciplinary research initiatives
at Florida International University (FIU),
directed towards eliminating health
disparities and assisting investigators of
the FIU center called CRUSADA (Center for
Research on US Latinos HIV/AIDS and Drug
Abuse), which was created under a grant
awarded by the NIH National Center on
Minority Health and Health Disparities for
2007-2012 to Mario De La Rosa (PI, and
Director) under the title, “C-SALUD: Center
for Substance Use and AIDS Research on
Latinos in the USA.” Two full research
projects and four pilot projects are
proposed as part of the core. All these
projects focus on the social and cultural
factors underlying the twin epidemics of
HIV/AIDS and substance abuse among
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
HIV Prevention Groups for AOD
Using SMI Women
INVESTIGATORS
Robert Malow (PI), Jessy
Dévieux (Co-PI), Mark
MacGowan (Co-Inv), Amy
Paul Ward (Co-Inv),
Michèle Jean-Gilles (Inv),
Brenda Lerner (Project
Director)
DEPARTMENT
AIDS Prevention
Program, Department of
Health Promotion &
Disease Prevention and
Stempel College of Public
Health and Social Work
SCIENTIFIC AREA
Latino populations, the theme of the
Center of Excellence; NCMHD, Research
Core, 2010-2011
Consists of an R01 randomized controlled
trial of an adapted intervention, “Let’s
Chat: A Brief Behavioral Skills Intervention
(BBSI) to Prevent HIV Infection Among
Chronic Mentally Ill Adults,” strengthened
to be gender and culturally appropriate for
a target population of alcohol and other
drug (AOD) using, seriously mentally ill
(SMI) women in outpatient treatment; The
analytical and therapeutic foreground of
the study is group process and its role as a
putative change mechanism. NIDA
(Primary), NIAAA, 2004-2009
BUREAU OF HIV/AIDS – 9 Studies
Presenters: Spencer Lieb, M.P.H. & Marlene LaLota, M.P.H.
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
HIV Prevalence Rates Among
Men Who Have Sex with Men in
the Southern United States:
Population-Based Estimates by
Race/Ethnicity
HIV Prevalence Rates Among
Men Who Have Sex with Men in
the Southern United States:
Population-Based Estimates by
Race/Ethnicity
Estimated HIV Incidence,
Prevalence, and Mortality Rates
Among Racial/Ethnic
Populations of Men Who Have
Lieb S, MPH, Fallon S, PhD,
Friedman S, PhD,
Thompson D, MPH, Gates
G, PhD, Liberti T, BS, and
Malow R, PhD
Spencer Lieb, Joseph
Prejean, Daniel R.
Thompson, Stephen J.
Fallon, Hannah Cooper,
Gary J. Gates, Thomas M.
Liberti, Samuel R.
Friedman and Robert M.
Malow
Lieb, Spencer MPH; White,
Stefanie MPH; Grigg, Becky
L PhD; Thompson, Daniel R
MPH; Liberti, Thomas M
Public Health Reports 2011
MSM and HIV
AIDS and Behavior 2010
MSM and HIV
Journal of Acquired
Immune Deficiency
Syndromes 2010
MSM and HIV
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
Sex with Men, Florida
Estimating Populations of Men
Who Have Sex with Men in the
Southern United States
Men Who Have Sex with Men:
Racial/ethnic Disparities in
Estimated HIV/AIDS Prevalence
at the State and County Level,
Florida
Men Who Have Sex With Men:
Estimated Population Sizes and
Mortality Rates by
Race/Ethnicity, Miami-Dade
County, Florida
Medical Monitoring Project
Protocol Title: TLC-Plus: A
Study to Evaluate the
Feasibility of an Enhanced Test,
Link to Care, Plus Treat
Approach for HIV Prevention in
the United States
National HIV Behavioral
Surveillance (Miami-Dade
County site)
INVESTIGATORS
BS; Fallon, Stephen J PhD
Lieb S, Thompson D, Misra
S, Gates G, Duffus W,
Fallon S, Liberti T, Foust E,
Malow R, and the
Southern AIDS Coalition
Team
Lieb S, Thompson D,
Santana A, Liberti T,
Maddox M, Bush T, Fallon
S
Lieb S, Trepka MJ,
Thompson D, Arons P,
Liberti T, Maddox L,
Metsch L, LaLota M,
Fallon S
Grigg, Becky L PhD
DEPARTMENT
Journal of Urban Health
2009
MSM and HIV
AIDS and Behavior 2009
MSM and HIV
Journal of Acquired
Immune Deficiency
Syndromes 2007
MSM and HIV
Supplemental HIV/AIDS
Surveillance
Persons receiving HIV medical care in
public and private facilities in Florida.
PI: Becky Grigg, PH.D,
Florida Dept. of Health,
Bureau of HIV/AIDS,
Surveillance
Marlene LaLota, Lisa
Metsch, David Forrest,
Dano Beck
SCIENTIFIC AREA
Funded By: Fred Hutchinson Cancer
Research Center,
Plus 0000698642 National Institute of
Child Health and Human Development
(NICHD)
Behavioral studies
Behavioral surveillance among high-risk
populations (i.e., MSM, IDUs, and
heterosexuals at increased risk for
infection). This ongoing study was first
implemented in 2004. Each population is
sampled approximately once every three
years; two study cycles have been
completed among each population. The
study provides data on 1) trends in sexual
and drug-use risk behaviors, 2) HIV
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
prevalence and incidence, 3) HIV testing
patterns, and 4) the use and impact of
prevention services. The overarching goal of
NHBS is to help evaluate and direct local
and national prevention efforts
University of Florida Center for HIV/AIDS Research Education and Service (UF CARES) – 11 Studies
Presented by Mobeen Rathore, M.D.
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
Calcium, Vitamin D and bone
mineral density in HIV infected
children compared to normal age
and sex matched subjects
(planning ongoing)
Dyslipidemia in HIV infected
children on HAART (ongoing)
Analysis of perinatal HIV
transmission in Florida 20022009 (completed)
Longitudinal Epidemiologic Study
to Gain Insight Into HIV/AIDS In
Children & Youth (legacy)
P1074: A Prospective Surveillance
Study of Long-Term Outcomes in
HIV-infected Infants, Children &
Adolescents, Version 1.0 dated
February 2, 2009 The IRB has
determined the risk/benefit for
this study is consistent with 45
CFR 45.404
PACTG P1055: Psychiatric CoMorbidity in Perinatally HIVInfected Children & Adolescents
Saran Valdez- Johnson
MD, Ayesha Mirza MD
Pediatrics
HIV and children and adolescents
Ayesha Mirza, Peter
Wludyka, Mobeen
Rathore
Ayesha Mirza, N Harrell, M
Lalota, L Maddox, Mobeen
Rathore
Pediatrics
Metabolic complications in HIV and children
UF Pediatrics and DOH,
Bureau of HIV/AIDS
Perinatal HIV transmission
Mobeen Rathore, MD
Pediatrics
HIV
Mobeen Rathore, MD
Pediatrics
HIV, long-term outcomes, chart review
Mobeen Rathore, MD
Pediatrics
HIV, children, Psychiatric
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Evaluation of Lipid Profiles on HIV
Infected Patients on HAART
Mobeen Rathore, MD
Pediatrics
Lipid disorders, HIV infection, serum
cholesterol
Improving Hepatitis C testing
compliance among infants born
to Hepatitis C and HIV infected
mothers
Perinatal Core Protocol, PACTG
1025 Includes Substudy:
IMPAACT P1026s:
Pharmacokinetic Properties of
Antiretroviral Drugs During
Pregnancy
Surveillance Monitoring for ART
Toxicities Study in HIV-uninfected
Children Born to HIV-infected
Women (SMARTT study) (PH100)
The Antiretroviral Pregnancy
Registry
Mobeen Rathore, MD
Pediatrics
Mobeen Rathore, MD
Pediatrics
HIV
Mobeen Rathore, MD
Pediatrics
HIV
Isaac Delke, MD
Pediatrics
HIV, antiretrovirals
BROWARD CHILDREN’S DIAGNOSTIC & TREATMENT CENTER - 13 Studies
Presented by Ana Puga, M.D.
BEHAVIORAL/EPIDEMIOLOGICAL
ATN 071/101: Neurocognitive
Assessment in Youth Initiating
Highly Active Antiretroviral
Therapy (HAART)(recruiting 101
Ana Puga, MD
Doyle Patton, PhD
CFAP Research
Neurocognitive impact of HIV in youth
Ana Puga, MD
CFAP Research
Adherence in youth
Ana Puga, MD
Marie Hayes, MSW
CFAP Research
Youth Linkage to Care Study
only)
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
ATN 078: A Pilot Study Using Cell
Phone Interactions to Improve
Medication Adherence in
Adolescents Who Have Previously
Failed Antiretroviral therapy due
to Non-Adherence. (on-going)
ATN 093: Evaluation of Strategic
Multisite Initiative for the
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BASIC SCIENCE/VIROLOGY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
Identification, Linkage, and
Engagement (SMILE) in Care of
Youth (recruiting)
ATN 096: Identifying
Undiagnosed Asymptomatic HIV
Infection in Hispanic/Latino
Adolescentn and Young Adults
(recruiting)
IMPAACT 1074: A Prospective
Surveillance Study of Long-Term
Outcomes in HIV-Infected Infants,
Children and Adolescents
(recruiting)
IMPAACT P1080: A Pilot Study of
Psychiatric and Antiretroviral
Medication Concentrations in
HIV-1 Infected and Uninfected
Children and Adolescents
(recruiting)
IMPAACT P1085 : Duration of
Human Papilloma Virus (HPV)
Type-Specific Antibody After
Administration of Quadrivalent
HPV Vaccine to HIV-1 Infected
Children Preciously Enrolled in
IMPAACT P1047 (recruiting)
PACTG 1025: Perinatal Core
Protocol (recruiting)
PH 201 AMP Memory Study:
Memory Functioning in Children
and Adolescents with Perinatal
HIV Infection (recruiting)
PH100 SMARTT: PHACS 100:
Surveillance Monitoring for ART
Toxicities in HIV-uninfected
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Ana Puga, MD
CFAP Research
HIV Testing
Ana Puga, MD
CFAP Research
Prospective long term follow-up of
Children/Youth on Highly Active
Antiretroviral Therapy (HAART)
Ana Puga, MD
CFAP Research
Psychiatric medications and antiretroviral
medication pharmacokinetics
Ana Puga, MD
CFAP Research
Duration of HPV antibodies post-vaccination
Ana Puga, MD
CFAP Research
Perinatal Observational Study
Ana Puga, MD
CFAP Research
Neuropsychology and HIV in Children
Ana Puga, MD
CFAP Research
Antiretroviral (ART) toxicity monitoring in
HIV exposed and infected infants
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
Children Born to HIV-infected
Women (SMARTT Study).
Version change includes SMARTT
Reference Cohort Sub Study and
SMARTT Nutrition Sub Study
(recruiting)
PH100 SMARTT REFERENCE: A
Study of the Effect of Maternal
Health in Pregnancy on Health
and Development of Infants and
Children (recruiting)
PH200 AMP: PHACS 200:
Adolescent Master Protocol
(AMP). (recruiting)
SMARTT NUTRITION: SMARTT
Nutrition Component (recruiting)
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Ana Puga, MD
CFAP Research
Unexposed control cohort for SMARTT
Ana Puga, MD
CFAP Research
Long term follow-up of perinatally infected
youth and perinatally HIV exposed youth
Ana Puga, MD
CFAP Research
Nutrition for HIV positive pregnant women
ClinicalTrials.gov Website Studies – 18 Additional Studies
BEHAVIORAL/EPIDEMIOLOGICAL
Identifying Undiagnosed
Asymptomatic HIV Infection in
Hispanic/Latino Adolescents and
Young Adults
(Effectiveness of AVT strategy with SS
NIT;
Facilitators & barriers to HIV testing;
Sub-group differences)
Eunice Kennedy Shriver
National Institute of Child
Health and Human
Development (NICHD)
National Institute on Drug
Abuse (NIDA)
National Institute of
Mental Health (NIMH)
Cherrie B. Boyer, Ph.D.,
Jonathan M. Ellen, M.D.,
Adolescent Trials Network
The proposed research will include adolescent and young adult Hispanic/Latino
men who have sex with men (MSM) and heterosexual men and women, aged
13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units
(AMTUs) that provide clinical care and psychosocial services to the target group.
In 10 of the 13 sites, comparisons will be made between alternative venuebased testing (AVT) and social and sexual network-based interviewing and HIV
testing (SSNIT) strategies to assess which, among these approaches, is the most
effective means for identifying undiagnosed human immunodeficiency virus
(HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on
use of SSNIT for identifying undiagnosed HIV in our target group of adolescents
and young adults. All study participants will complete an audio computerassisted self-interview (ACASI) and undergo HIV screening. Participants with
presumptive HIV positive screening results will be referred to the local AMTU for
confirmatory testing, post-test counseling and referrals for linkage to HIV
medical care. Linkage to care for ATN 096 study participants will be conducted in
accordance with the Strategic Multisite Initiative for the Identification, Linkage,
and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in
CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and
NICHD/ATN, to ensure that youth who test positive for HIV as part of this
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
protocol are linked with treatment and care.
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
Safety of and Immune Response to
an H1N1 Influenza Vaccine in HIV
Infected Pregnant Women
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID)
Sharon Nachman, MD, State
University of New York at
Stony Brook
Pfizer CT.gov Call Center
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
Safety of and Immune Response to
the Human Papillomavirus (HPV)
Vaccine in HIV-Infected Women
Efficacy and Safety of GSK Biologicals
HIV Vaccine in Antiretroviral Therapy
(ART)-naïve HIV-1 Infected Persons
Pharmacokinetic Study of Anti-HIV
Drugs During Pregnancy
National Institute of Allergy
and Infectious Diseases
(NIAID); National Institute of
Dental and Craniofacial
Research (NIDCR)
Erna Milunka Kojic, MD,
Department of
Immunology/Infectious
Disease, The Miriam Hospital,
Brown University;
Susan Cu-Uvin, MD,
Obstetrics-Gynecology and
Medicine, The Miriam
Hospital, Brown University
GSK Clinical Trials
National Institute of Allergy
and Infectious Diseases
(NIAID); Eunice Kennedy
Shriver National Institute of
Child Health and Human
Development (NICHD)
Mark Mirochnick, MD,
Adverse events (AEs) of all grades; AEs of all grades attributed to the study vacc
ine; Withholding of second vaccine dose due to adverse reactions attributed to
first dose; Immunologic response, defined as hemagglutination inhibition (HAI)
titer of at least 1:40; Maternal immunologic response, defined as HAI of at least
1:40; Infant HAI of at least 1:40; Maternal geometric mean titers (GMT) of
antibodies HAI; Infant GMT of antibodies HAI; Maternal cell-mediated
immunity (CMI) responses, as measured by B-cell and T-cell enzyme-linked
immunosorbent spot (ELISPOT) assay
values; CD4 count; HIV RNA copies/ml; Response to seasonal trivalent
influenza vaccine (TIV); Exploration of factors related to HIV and its treatment
that might affect the response to H1N1 vaccinations
Type-specific HPV antibody development from the seronegative status at
baseline to seropositive status a month after the completion of HPV vaccination
series (Week 28) for HPV types 6, 11, 16, and
18; Occurrence of Grade 3 or greater adverse events; HPV antibody titers to ty
pes 6, 11, 16, 18; Longitudinal changes in HIV viral load; Nadir and baseline CD
4 count; Baseline HIV viral load; Cellular immune response assay data from
the subset of U.S. participants; Longitudinal changes in CD4+ cell count from
baseline
This study is designed to determine whether administration of the GSK
Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact
on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV1 infected persons who have not yet started antiretroviral therapy (ART), such a
vaccine would potentially lead to a delay in the initiation of treatment.
The purpose of this study is to determine what doses of anti-HIV medications
are appropriate for pregnant women.
Anti-HIV medication taken during pregnancy may control a woman's viral load
and reduce the chance that the baby will become infected with HIV. Pregnant
women may require different doses of anti-HIV drugs than women who are not
pregnant. This study will use pharmacokinetic (PK) sampling to determine what
doses of anti-HIV medications are best for HIV-infected pregnant women and
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Boston Medical Center
their infants.
A Phase 2b Open-Label Rollover
Study For Subjects Discontinuing
From UK-453,061 Studies For The
Treatment Of HIV-1 Infected Subjects
An Open-Label, Extension Safety Trial
Of Pregabalin In Subjects With
Neuropathic Pain Associated With
HIV Neuropathy (Pregabalin
A0081251)
Strategic Timing of Antiretroviral
Treatment (START)
Pfizer CT.gov Call Center
The purpose of the protocol is to assess long-term safety and tolerability of
subjects who discontinue for any reason from UK-453,061 qualifying studies.
Pfizer CT.gov Call Center
This study examines the safety of pregabalin over a 6 month period in patients
with neuropathic pain associated with HIV infection as an extension of another
trial that tests the efficacy of pregabalin.
University of Minnesota Clinical and Translational
Science Institute
High Dose Chemotherapy With
Autologous Stem Cell Rescue for
Aggressive B Cell Lymphoma and
Hodgkin Lymphoma in HIV-infected
Patients (BMT CTN 0803)
Joseph Alvarnas, MD, City of
Hope National Medical
Center
Richard Ambinder, MD, Johns
Hopkins Medical Institution
National Heart, Lung, and Blo
od Institute (NHLBI); Nation
al Cancer Institute (NCI); Blo
od and Marrow Transplant
Clinical Trials Network
Ruth Tuomala, MD,
Director of Obstetrics and
Gynecology, Brigham and
Women's Hospital; Gwen
Scott, MD, Pediatric
Infectious Diseases,
University of Miami School of
Medicine
International Maternal
Pediatric Adolescent AIDS
To find out if the chance of developing a serious illness or of getting AIDS is less
if patients start taking HIV medicines at a time when their CD4+ cell count is still
fairly high, instead of waiting until the CD4+ count is at the level where there is
good evidence for starting medicines.
To learn more about how a strategy of starting HIV medicines early might affect
other aspects of care, such as the chances of developing other illnesses or
resistance to HIV medicines, the frequency of doctor visits, the cost of medical
care, and general health and satisfaction.
This study is a Phase II, multicenter trial assessing overall survival after
autologous hematopoietic stem cell transplantation using a BEAM transplant
regimen in lymphoma patients with HIV.
Perinatal Core Protocol
(Prenatal and Postnatal Studies of
Interventions for Prevention of
Mother-To-Child Transmission)
The purpose of this study is to collect and study clinical and laboratory
information about a pregnant or new mother and her medical care that will
increase our knowledge of the best care for HIV-infected pregnant women and
their children.
The rate of transmission of HIV from mothers to their infants has gone down.
Specific U.S. Public Health Service guidelines recommend that HIV-infected
pregnant women be treated with anti-HIV therapies; but the effectiveness of
treatment and safety for the mother and her infant have not been fully
examined. This study will monitor the health of women and their infants while
they receive anti-HIV therapy. Also, this study will provide information that may
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Clinical Trials Group; Nat’l
Inst. of Allergy and Infectious
Diseases (NIAID); Eunice
Kennedy Shriver National
Institute of Child Health and
Human Development
(NICHD)
Ann Melvin, MD, Seattle
Children's Hospital;
John Farley, MD,
University of Maryland at
Baltimore
International Maternal
Pediatric Adolescent AIDS
Clinical Trials Group;
National Institute of
Allergy and Infectious
Diseases (NIAID);
Eunice Kennedy Shriver
National Institute of
Child Health and Human
Development (NICHD)
be used for future studies.
Computer-Delivered Motivational
Intervention to Prevent Adherence
Problems Among Youth Newly
Recommended for HIV Medications:
Project MESA (Motivational
Enhancement System for Adherence)
Sylvie Naar- King, PhD,
Adolescent Trials Network
Eunice Kennedy Shriver
National Institute of
Child Health and Human
Development (NICHD);
National Institute on
Drug Abuse (NIDA);
National Institute of
Mental Health (NIMH)
Maraviroc Plus Darunavir/Ritonavir
Study for Treatment-Naïve Patients
Infected With R5-tropic HIV-1 Based
on Enhanced Sensitivity Trofile
NCT00993148
Principal Investigator: Jose
Castro, M.D. (U of Miami);
Babafemi Taiwo, MD,
Northwestern University
Pfizer
This is a two-phase study, consisting of the following plan:
Phase I - This is a pre-test of the feasibility and acceptability of the beta version
of a computer-delivered intervention, Motivational Enhancement System for
Adherence (MESA), as well as the control intervention Motivational
Enhancement System for Health (MESH) at three selected AMTUs. Following
analysis of the responses in Phase I and further modification of the intervention,
Phase II will be initiated.
Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session
computer-delivered intervention, MESA, designed to increase motivation for
adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly
recommended to begin medications, as well as an attention control, MESH,
matched for dose and delivery format. Phase II is open to all 15 AMTUs.
The objective of this study is to evaluate the safety and efficacy of a novel
combination antiretroviral therapy regimen consisting of maraviroc plus
darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1.
The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1,
combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is
Phase I/II Safety and Efficacy
Investigation of Atorvastatin for
Treatment of PI-Associated Increased
LDL Cholesterol in HIV-Infected
Children and Adolescents
Treatment of HIV with antiretroviral regimens that include protease inhibitors
(PIs) frequently results in the suppression of HIV viral load, significant immune
recovery, and delayed disease progression. However, treatment with PIs has
been associated with significant increases in cholesterol and triglycerides in HIV
infected adults and children. The purpose of this study is to evaluate the safety
and effectiveness of escalating doses of atorvastatin, a FDA-approved drug
which lowers cholesterol and triglyceride levels, in HIV infected children
receiving antiretroviral regimens containing at least one PI.
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STUDY CATEGORY
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
Study to Test Meta-intervention to
Increase Retention in HIV Prevention
Counseling
(This may be a duplication – see
Duval CHD on page 14 ±)
INVESTIGATORS
BEHAVIORAL/EPIDEMIOLOGICAL
A Phase II Trial of Response-Adapted
Therapy of Stage III-IV Hodgkin
Lymphoma Using Early Interim FDGPET Imaging
NCT00822120
SCIENTIFIC AREA
Tibotec, Inc
well tolerated and efficacious.
University of Illinois at UrbanaChampaign
Collaborators: Duval County
Health Department
Unfortunately, people most at risk for HIV are the least likely to enroll and
remain in prevention programs. In our past work, we have learned how to
increase enrollment in such programs among this group. We have identified and
addressed previously ignored gender-specific and client self-validation issues
that conventional interventions often leave not only uncontrolled, but often
biased against participation. The present work will extend these methods from
enrollment to retention.
We intend to recruit a sample of 656 at-risk participants through our
collaboration with the Duval County, FL Health Department for our randomized,
double-blind trial. Our study will investigate if a meta-intervention video
designed for empowering participants as agents of their own change can
increase the number of attended sessions relative to a control condition without
such a video. This trial will also determine if a meta-intervention video
addressing various emotional/social and instrumental benefits of an HIVprevention-counseling intervention can also increase the number of attended
sessions. These two factors will be crossed, and their effects on retention will be
estimated for different genders and ethnicities. Effects on clients' attention to
the return sessions as reported by the counselor will also be explored among
participants who return.
We will also conduct mediator analyses for investigating if the metaintervention has mediating influences on corresponding expectations about the
return counseling session. As the inclusion of meta-cognitive measures can alter
the efficacy of the intervention, half of the sample will receive measures
immediately (0-10 minutes) after exposure to the meta-intervention, before
attendance to the next session is registered. The other half will not complete
these measures
RATIONALE: Drugs used in chemotherapy work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more
cancer cells. G-CSF may help lessen the side effects in patients receiving
chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT
imaging, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to
see how well it works in assessing response to combination chemotherapy and
allow doctors to plan better additional further treatment in treating patients
with stage III or stage IV Hodgkin lymphoma.
Dolores Albarracin, PhD
William Livingood, PhD, Duval
CHD
CLINICAL TRIAL
DEPARTMENT
M.D. Anderson Cancer
Center at Orlando
Recruiting
Orlando, Florida
Contact:
Julio J. Hajdenberg, MD
321-841-7219
Southwest Oncology Group
National Cancer Institute (NCI)
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STUDY CATEGORY
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
An International Observational Study
to Characterize Adults Who Are
Hospitalized With Complications of
Influenza A – Pandemic H1N1
(H1N1v); NCT01056185
INSIGHT H1N1v Outpatient Study
(FLU 002)
Official Title: An International
Observational Study to Characterize
Adults With Influenza A – Pandemic
H1N1 (H1N1v); NCT01056354
INVESTIGATORS
University of Minnesota –
Clinical and Translational
Science Institute
National Institute of Allergy
and Infectious Diseases (NIAID)
National Institutes of Health
(NIH)
Infectious Diseases Associates
NW FL, PA
Pensacola, Florida, United
States, 32504
Contact: Barbara He Wade,
MD, FACP
bwade@infectioncenter.com
850-476-3131
Principal Investigator: Barbara
He Wade, MD, FACP
University of Minnesota –
Clinical and Translational
Science Institute
National Institute of Allergy
and Infectious Diseases (NIAID)
National Institutes of Health
(NIH)
Infectious Diseases Associates
NW FL, PA
Pensacola, Florida, United
States, 32504
Contact: Barbara He Wade,
MD, FACP
bwade@infectioncenter.com
850-476-3131
Principal Investigator: Barbara
He Wade, MD, FACP
DEPARTMENT
SCIENTIFIC AREA
The “flu” is a common disease and usually mild, but severe disease and death
may occur. There are several types of flu viruses and they change over time.
Recently, a new influenza A virus known commonly as swine flu or H1N1v has
emerged. This flu has spread rapidly around the world. It is important to
understand the course of illness for those who have H1N1v and the
characteristics of people who do not do well. The investigators will also try to
learn more about how different treatments and prior vaccination for the flu
affects the course of the illness. Approximately 1,000 individuals will be enrolled
in several countries around the world. The results of this study will be used to
advise on the management of patients who are hospitalized with the flu.
The "flu" is a common disease and usually mild but severe disease and deaths
may occur. There are several types of flu viruses and they change over time.
Recently, a new influenza A virus known commonly as swine flu or H1N1v has
emerged. This flu has spread rapidly around the world. It is important to
understand the course of illness for those who have H1N1v and the
characteristics of people who do not do well. The investigators will also try to
learn more about how different treatments and prior vaccination for the flu
affect the course of the illness. Approximately 5,000 individuals with swine flu
will be enrolled in several countries around the world.
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STUDY CATEGORY
CLINICAL TRIAL
BEHAVIORAL/EPIDEMIOLOGICAL
PROJECT TITLE
Isotretinoin With or Without
Monoclonal Antibody, Interleukin-2,
and Sargramostim Following Stem
Cell Transplantation in Treating
Patients With Neuroblastoma
Official Title: Phase III Randomized
Study Of Chimeric Antibody 14.18
(CH14.18) In High Risk
Neuroblastoma Following
Myeloablative Therapy And
Autologous Stem Cell Rescue
NCT00026312
INVESTIGATORS
Numerous locations
throughout Florida
CHILDREN'S ONCOLOGYGROUP
; NATIONAL CANCER
INSTITUTE (NCI)
Under 30 yrs old
Study Chair:
Alice L. Yu, MD, PHD
UC at San Diego
DEPARTMENT
SCIENTIFIC AREA
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor
cells from dividing so they stop growing or die. Monoclonal antibodies can
locate tumor cells and either kill them or deliver tumor-killing substances to
them without harming normal cells. Interleukin-2 and sargramostim may
stimulate a person's white blood cells to kill cancer cells. It is not yet known if
chemotherapy is more effective with or without monoclonal antibody therapy,
interleukin-2, and sargramostim following stem cell transplantation in treating
neuroblastoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of
chemotherapy with or without monoclonal antibody, interleukin-2, and
sargramostim following stem cell transplantation in treating patients who have
neuroblastoma
TOTAL NUMBER OF BEHAVIORAL STUDIES LISTED AS OF 9/29/11 = 160
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STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
BASIC SCIENCE
UNIVERSITY OF CENTRAL FLORIDA – 4 Studies
Presenter: Alexander M. Cole, Ph.D.
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
Retrocyclins: circular defensins
active against HIV-1 (NIH R01
grant AI052017)
Project 2. Development of RC101 as an intravaginal topical
microbicide. (NIH U19 grant
AI082623)
Aminoglycoside microbicides
restore natural anti-HIV-1
retrocyclins (NIH R21 grant
AI082693)
Reawakening retrocyclins to
prevent mucosal STIs (Gates
Grand Challenges Explorations
Award)
Alexander M. Cole, Ph.D.
(PI)
Microbiology and
Molecular Biology
Topical microbicides to prevent HIV-1
transmission
Alexander M. Cole, Ph.D.
(PD of Project 2); Phalguni
Gupta, Ph.D. (PI; PD of
Project 3; U. Pitt); other
project and core directors
Alexander M. Cole, Ph.D.
(PI)
Microbiology and
Molecular Biology
Topical microbicides to prevent HIV-1
transmission
Microbiology and
Molecular Biology
Innate host defense against HIV-1
Alexander M. Cole, Ph.D.
(PI)
Microbiology and
Molecular Biology
Innate host defense against STIs, including HIV
UNIVERSITY OF MIAMI – 36 Studies
Presenter: Savita Pahwa, M.D.
BASIC SCIENCE/VIROLOGY
Targeted siRNA delivery as an
anti-HIV microbicide
Derek Dykxhoorn
BEHAVIORAL/EPIDEMIOLOGICAL
Longitudinal analysis of a high
risk HIV negative cohort
Derek Dykxhoorn (Human
Genetics, Microbiology and
Immunology, DCFAR), Lisa
Metsch (Epidemiology and
BASIC SCIENCE/VIROLOGY
Dr. John T. Macdonald
Foundation Department
of Human Genetics and
the Department of
Microbiology and
Immunology
Human Genetics,
Microbiology and
Immunology,
Epidemiology and Public
Microbicide development
Genetics and Genomics of HIV infection,
Acute HIV infection (AHI)
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STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
Public Health, DCFAR), Jose
Castro (Medicine, DCFAR),
Savita Pahwa (Microbiology
and Immunology, DCFAR),
Margaret Fischl (Medicine,
DCFAR), Rafick Sekaly (VGTIFlorida, DCFAR), Lydie
Trautmann (VGTI-FL,
DCFAR)
Derek Dykxhoorn (Human
Genetics, Microbiology and
Immunology, DCFAR),
Hector Bolivar (Medicine,
DCFAR), William Scott
(Human Genetics, DCFAR)
Mario Stevenson (PI)
Health, Medicine, VGTIFL, Developmental
Center for AIDS
Research (DCFAR)
Mario Stevenson (PI) Keith
Mansfield (Harvard)
Mario Stevenson (PI)
Medicine
Preclinical Development of HIV-1
Vif Antagonists
Mario Stevenson (PI) Tariq
Rana (Burnham), Keith
Mansfield (Harvard), Brigitte
Beer (Bioqual)
Medicine
Molecular characterization of
cryptic HIV-1 replication during
HAART (Project 1)
Mario Stevenson (PI) Tim
Schacker (U. Minnesota)
Medicine
Pharmacokinetics of HIV-1 with
the integrase inhibitor
Raltegravir
Mario Stevenson, Rafael
Campo (PI)
Medicine
Identification of genetic
variations associated with viral
set point control in long term
non-progessors
Activation of CD40 by HIV and
Role in AIDS Dementia
Role of Monocytotropism in
HIV/SIV Pathogenicity
Cellular Co-Factors of HIV-1
Infection
Human Genetics,
Microbiology and
Immunology, Medicine,
VGTI-FL, Developmental
Center for AIDS
Research (DCFAR)
Medicine
Medicine
SCIENTIFIC AREA
Genetics of HIV infection
Identify mechanism by which HIV induces
neuronal destruction in AIDS dementia
Examine the role of myeloid lineage cells in
the persistence & pathogenicity of HIV/SIV
Identify cellular factors that are
commandeered by HIV in its replication
cycle. The goal is to identify new targets for
therapeutic intervention
Undertake preclinical development of a lead
molecule that interferes with the action of
the HIV Vif protein.
To identify the viral reservoirs that persist in
the face of antiretroviral therapy. Our
analysis focuses on the role of the gut
lymphoid tissue in viral persistence.
To evaluate whether intensification of ART
with Raltegravir reduces the extent of
aberrant immune activation and improves
on-treatment CD4 gains in HIV infection
individualS
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STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
The Role of Myeloid Cells in Viral
Replication, Persistence and
Neuroinvasion
Mario Stevenson (PI)
Medicine
HIV Exposed Uninfected:
Adaptive Immunity
Jose Castro, Margaret
Fischl, Rafick Sekaly
UM Developmental Center For
AIDS Research Int'l AIDS
Malignancy Initiative Program
DCFAR- SCCC International
Collaborations in AIDSMalignancies
International Maternal Pediatric
Adolescents AIDS Clinical Trails
Group Immunology Laboratory
Role of IL21 in HIV infection
Enrique Mesri
Microbiology and
Immunology, Medicine,
VGTI
Microbiology and
Immunology
Effect of Raltegravir on immune
activation, immune
reconstitution and gut microbial
translocation in patients with
chronic HIV infection
Induction of mucosal SIV
immunity in non human
primates by secreted Hsp-Gp96
HIV Exposed Uninfected: Innate
Immunology
Savita Pahwa
Targeted therapy for Burkitt
Lymphoma in Resource Poor
Settings
Targeting of EBV Latency in
Enrique Mesri, Gail ShorPosner, Juan Carlos Ramos
SCIENTIFIC AREA
To determine whether macrophage are a
source of persistent virus in patients on ART
& to develop a strategy to remove infected
macrophage reservoirs using agents that
promote macrophage apoptosis
Pathogenesis, Mucosal Immunity
NCI
Microbiology and
Immunology, Medicine,
Pediatrics
Microbiology and
Immunology
AIDS Malignancies Projects in Brazil and
Argentina
NIH
NIAID
Microbiology and
Immunology
Microbiology and
Immunology
NIAID
Eckhard Podack, Savita
Pahwa
Microbiology and
Immunology
NIAID
Lydie Trautmann, Margaret
Fischl, Rafick Sekaly
Pathogenesis, Mucosal Immunity
Barber Glen
Microbiology and
Immunology, Medicine,
VGTI
Medicine
Juan Carlos Ramos
Medicine
NCI
Savita Pahwa,
Savita Pahwa
Merck
NCI
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STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
Burkitt's Lymphoma
Biochemical Mechanisms of
Drug Resistance in HIV RT
Mitochondrial determinations
metabolic disease in HIVinfected children
Ologonucelotide apatmer
ligands to reverse T cell anergy
HIV-infected patients
Effect of Raltegravir on immune
activation, immune
reconstitution and gut microbial
translocation in patients with
chronic HIV infection
HIV-1 C clade progression and
neuroaids
Gp96-Ig HIV and SIV vaccines;
HPV based HIV vaccines
INVESTIGATORS
Walter A. Scott
DEPARTMENT
SCIENTIFIC AREA
Biochemistry &
Molecular Biology
Pediatric Metabolic/
Pathogenesis Research
NIAID
Eli Gilboa
Novel therapeutics and
pathogenesis
NIAID
Rafael Campo
Savita Pahwa
Mario Stevenson
Novel therapeutics and
pathogenesis
Merck
Mahendra Kumar
Pathogenesis
NINDS
Vaccine Research
R21, R33 funded; PO1, UO1 pending (NIAID)
Vaccine Research
R21, K22, R21 pending NIAID
Tracie Miller
NINR
BASIC SCIENCE/VIROLOGY
Novel adjuvants
Podack, E. R; Franchini, G
(NCI); Haddad, E (VGTI);
Sekaly, R. (VGTI) Pahwa, S;
Altman, N
Stone, G.
BASIC SCIENCE/VIROLOGY
TL1A and LMP1
Strbo, N; Stone, G.
Vaccine Research
DCFAR/ NIAID Supplements
Hu-mice for HIV vaccine
research
Host Defense Regulation and
Viral Oncogenesis
Role of RAC and Reactive
Oxygen Species in Kaposi’s
Sarcoma Viral Oncogenesis
Biology of KSHV/HHV8 G Protein
Coupled Receptor
Gonzales, L; Strbo, N;
Podack E.R.
Vaccine Research
AIDS Malignancies
Predoctoral stipend from HIV training grant
(NIMH)
NCI
AIDS Malignancies
NCI
AIDS Malignancies
NCI
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
Glen Barber
Enrique Mesri
P Goldschmidt
Enrique Mesri
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STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
A Prospective, Open-Label,
Double-Arm, Crossover, SingleCenter Pilot Study to Evaluate
the Addition of Raltegravir to
Established Suppressive
Antiretroviral Therapy while
Monitoring Changes in Markers
of Immune Activation among
HIV-1 Infected Individuals
Without Adequate Immune
Restoration. (35835)
140 - Clinical Evaluation of the
Xpert® CT/NG Assay
73B - Evaluation of the Xpert®
CT/NG Assay
Effect of Raltegravir on immune
activation, immune
reconstitution and gut microbial
translocation in patients with
chronic HIV infection
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Rafael Campo
Medicine
Immune reconstitution
Jose Castro
New – enrolling soon
Jose Castro
New Enrolling soon
Medicine
Efficacy
Medicine
Efficacy
Industry Studies
Immune reconstitution
UNIVERSITY OF SOUTH FLORIDA – 13 Studies
Presenter: John W. Sleasman, M.D.
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
R01 AI47723-04A1; NIAID.
Impact of HIV-1 Genotype on
Therapy Response in Children
Defective immunoglobulin
somatic hypermutation results
in pneumococcal vaccination
hyporesponsiveness in HIV
infected children. Center for
John Sleasman, MD (PI),
Carina Rodriguez, MD,
Soichi Haraguchi, PhD,
Patricia Emmanuel, MD
(Co-Investigators)
Carina Rodriguez, MD (PI),
John Sleasman, MD, Li Yin,
PhD, Maureen Goodenow,
PhD.
Allergy and
Immunology
Impact of HIV resistance in immunologic and
viral responses in HIV-1 infected children and
adolescents
Pediatric Infectious
Diseases, Allergy and
Immunology (USF) and
Pathology (UF)
Impact of HIV infection on B cell repertoire and
somatic mutation and the role of vaccine
response
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STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
Florida AIDS Research
Do children with HIV have
disregulated amyloid loads in
their blood?
Substance use and immunity
function in HIV+ adolescents by
systems biology
Impact of HIV-1 Genotype on
Therapy Response in Children.
Role of HIV-1 Env Diversityin
Cellular Tropism
Studies of Ocular Complications
of AIDS (SOCA)
Defective immunoglobulin
somatic hypermutation results
in pneumococcal vaccination
hyporesponsiveness in HIV
infected children
Changes in the B cell repertoire
following vaccination with novel
H1N1 inactivated influenza
vaccine in immune deficient
adolescents and young adults
chronically infected with HIV
The Role of HIV-TAT in
Alzheimer’s Disease
Uncovering Co-stimulatory T Cell
Help Defects in Common
Variable Immunodeficiency
Green Tea Derived EGCG
Opposes AIDS Dementia-Like
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Brian Giunta, MD (PI),
Carina Rodriguez, MD,
Patricia Emmanuel, MD,
John Sleasman, MD, Jaime
Fernandez, MD, Frank
Fernandez, MD
Maureen Goodenow, John
Sleasman
Psychiatry and
Pediatric Infectious
Diseases
Changing levels of amyloid beta in peripheral
blood and HIV viral infection.
Basic/translational, immune response
Pathology, UF Allergy
and Immunology, USF
Maureen Goodenow, John
Sleasman
Pathology, UF Allergy
and Immunology, USF
Maureen Goodenow, John
Sleasman
Peter Pavan (PI)
Pathology, UF Allergy
and Immunology, USF
Ophthalmology
Substance use and immunity function in HIV
adolescents
Sponsor: NIDA
Structure function relationships between HIV-1
protease and p7NC.
Sponsor: NIAID
HIV-1 envelope and CD4 target cells.
Sponsor: NICHD
Complications, ocular diseases, AIDS, CMV
Carina Rodriguez (PI)
Pediatrics
basic/translational, immune response
Carina Rodriguez (PI)
Pediatrics
basic/translational, immune response
Richard Dembo (PI)
Psychiatry and
Neurosciences
Pediatrics
Prevention; Drug Use
Elena Perez (PI)
Jun Tan (PI)
Psychiatry and
Neurosciences
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STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
Neuronal Damage
Role of Cannabinoid 2 Receptors
in B Lymphocyte Function
INVESTIGATORS
Catherin Patterson (PI)
DEPARTMENT
SCIENTIFIC AREA
Biochemistry
UNIVERSITY OF FLORIDA
Presenter: Maureen Goodenow, Ph.D. - 14 studies
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
Substance use and immunity in
HIV+ infected adolescents by
systems biology
Human Immunodeficiency Virus
Proteinase
Role of HIV-1 Env Diversity in
Cellular Tropism
Impact of HIV-1 Genotype on
Therapy Response in Children
Characterization of novel
polyreactive anti-HIV antibodies
in autoimmunity
Molecular mechanisms of
skeletal muscle loss in HIVinfected older persons
Viral evolution in peripheral
Maureen Goodenow (PI),
Li Yin (Co-PI), Mark Wallet;
John W. Sleasman, USF, co
PI; Sharon Nichols,
University of California,
San Diego
Ben Dunn (PI), Maureen
Goodenow (Co-I)
Maureen Goodenow (PI),
Li Yin (Co-PI); John W.
Sleasman, co-PI USF
Pathology
HIV and adolescents
Pathology
John Sleasman (PI), USF,
Maureen Goodenow (CoPI)
Maureen Goodenow (PI),
Li Yin (Co-I), Mark Wallet;
John W. Sleasman, co-PI
USF
Pathology
Mechanisms of HIV drug resistance to
protease inhibitors
Mechanisms of HIV-1 entry into
macrophages and genetic determinants in
envelope that modulate macrophage
infection; deep pyrosequencing of HIV-1
variants in longitudinal study
Mechanisms of HIV-1 genotype and therapy
outcome in children
Marco Pahor (PI),
Christiaan Leeuwenburgh,
Maureen Goodenow,
Todd Manini, Bradley
Bender, Madhuri
Sankuratri, Kevin
Yarasheski, Martin Rhee
Marco Salemi (PI),
Geriatrics and Aging
Research; Pathology
Pathology
Pathology
Pathology
HIV vaccine; deep pyrosequencing of human
immunoglobulin repertoire and novel phage
display library from autoimmune individuals
to identify broadly neutralizing antibodies
against HIV-1
Effects of HIV-1 on strength and fatigue in
older infected individuals; peripheral blood
biomarkers of inflammation and innate
immune activation
Viral dynamics of neuroAIDS in macaque
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FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
Page 79 of 84
STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
macrophages and brain during
progression to AIDS
Alveolar Macrophage
Proteomics in HIV-Induced
Emphysema
Rational design of HIV fusion
inhibitors targeting GP 41
Human Immunodeficiency Virus
Proteinase
Combination of CCR5 32 and
SIRNAS targeting HIV
Analysis of HIV sequence data
Foamy virus vector for
Immunodeficiency viruses
therapy
Protective CMI mechanisms of a
dual subtype FIV Vaccine
INVESTIGATORS
Maureen Goodenow (CoI), Rebecca Gray
Thomas Clanton (PI)
DEPARTMENT
SCIENTIFIC AREA
model
Exercise and Sports
Sciences
Pathogenesis
Alan R. Katritzky (PI)
Chemistry
Drug Design
Ben M. Dunn (PI),
Maureen Goodenow (CoPI)
Lung-Ji Chang
Biochemistry and
Molecular Biology
Drug Therapy
Gene Therapy
Marco Salemi (PI)
Molecular Genetics &
Micro
Pathology
Ayalew Mergia (PI)
Pathobiology
Gene Therapy
Janet K. Yamamoto (PI)
Pathobiology
Vaccine
Molecular Epidemiology
STATE BUREAU OF LABORATORIES – 5 Studies
Presenter: Berry Bennett, M.P.H.
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
(Planned) Implementation of a
4th Generation HIV-1/2 Ag/Ab
Screening assay and a NonTraditional Confirmatory Process
Correlation on the Use of a
Reactive Signal to Cutoff
Threshold Value in a 3rd
Generation HIV-1/2 Antibody
Immunoassay to Expedite
Supplemental Testing and
Reduce Screening Costs. Poster,
2010 HIV Diagnostic Conference,
March 2010, Orlando
B. Bennett (PI), D. Willis,
M. Salfinger, M. Diamante
Retrovirology, Jacksonville
& Miami
Bennett B (PI), Fordan S,
Diamante M, et.al.
Retrovirology, Jacksonville
& Miami
Laboratory/Patient Care – HIV-1 acute
infection detection and the
implementation of a new HIV diagnostic
algorithm
Laboratory
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FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
Page 80 of 84
STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
Performance of the Aptima HIV1 RNA Qualitative Assay with
16- and 32-Member Specimen
Pools. Journal of Clinical
Microbiology, Vol. 48, No. 9,
Sept. 2010, p. 3343-3345
Cost-Effectiveness of Pooled
Nucleic Acid Amplification
Testing for Acute HIV Infection
after Third-Generation HIV
Antibody Screening and Rapid
Testing in the United States: A
Comparison of Three Public
Health Settings. PLoS Medicine,
Vol. 7, Issue 9, Sept. 2010,
e1000342
Detecting Acute Human
Immunodeficiency Virus
Infection Using 3 Different
Screening Immunoassays and
Nucleic Acid Amplification
Testing for Human
Immunodeficiency Virus RNA,
2006-2008, Archives of Internal
Medicine, Vol 170 (#1), Jan. 11,
2010
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Ethridge S (PI), Bennett, B,
Stephens, P, et.al.
Retrovirology, Jacksonville
& Albany; CDC and NYDOH
LABORATORY
Laboratory
Hutchinson A (PI), Bennett
B, et.al.
Retrovirology, Jacksonville
& Albany; CDC and
NYDOH LABORATORY
Laboratory
Patel P (PI), Bennett B,
Lalota M, Simmons P,
et.al.
Retrovirology, Jacksonville
& Albany; Prevention
Program; CDC and NY
LABORATORY
Laboratory/Prevention
FLORIDA INTERNATIONAL UNIVERSITY – 6 Studies
Presenter: Mario De La Rosa, Ph.D.
BASIC SCIENCE/VIROLOGY
Platelets Mediating Alcohol and
HIV Damage
Maria-Jose Miguez (PI)
Robert Stempel College of
Public Health and Social
Work
To evaluate platelets, platelet associated
factors, immune and cognitive function in
four groups: hazardous and non-hazardous
alcohol consuming HIV-infected subjects
and hazardous and non-hazardous alcohol
consuming HIV sero-negative subjects
Rev. 9/29/11
FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
Page 81 of 84
STUDY CATEGORY
PROJECT TITLE
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Funded by NIAAA
BASIC SCIENCE/VIROLOGY
Polydrug Nanocarrier to Treat
Opiate Addiction and HIV
Disease
Madhavan Nair (PI),
Zainulabedin Saiyed
Herbert Wertheim College
of Medicine
BASIC SCIENCE/VIROLOGY
Mechanisms of Neuro-AIDS by
HIV1B and C Clades
Madhavan Nair (PI), Robert
Malow, Zainulabedin
Saiyed
Herbert Wertheim College
of Medicine
BASIC SCIENCE/VIROLOGY
Cytokines An Underlying Cause
Of Health Disparities In Tobacco
Related Diseases
Maria Jose MíguezBurbano, MD, PhD (PI)
Florida International
University
BASIC SCIENCE/VIROLOGY
NIH NIAAA 1R01AA01809501 Title: Platelets Mediating
Alcohol and HIV Damage
Miguez, Malow, Nair
Florida International
University
To use state-of-the-art nanotechnology
for HIV drug targeting to brain affected by
Neuro-AIDS through the following specific
aims: To develop a magnetoliposome
based multifunctional nanocarrier bound
to CTOP, BDNF and AZTTP
To test the developed formulation in vitro
for its ability to transmigrate across BBB.
To evaluate the in vivo efficacy of the
developed nanocarrier in an HIVE SCID
morphine mouse model; Funded by NIDA
To investigate the molecular mechanisms
of clade-specific neuronal dysfunctions
associated with clade-specific HIV
infections, and to suggest novel anti-HIV
therapeutic research strategies to alleviate
the HIV induced neuronal dysfunctions in
HIV infected subjects; Funded by NIDA
The principal tasks of this five-year
longitudinal translational study, which
builds upon our previous work, are to
examine the immunological and
behavioral mechanisms underlying health
disparities in tobacco related diseases in
PLWH and PLWOH. Specifically, we
propose to search for disparities in the
gene expression and cytokine production
patterns. Funding: James and Esther King
Florida Health Department
The first aim of this 5 years longitudinal
study is to confirm an inverse relationship
between alcohol use and platelet counts
and explore putative mediating immune
Rev. 9/29/11
FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
Page 82 of 84
STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
NIH NIAAA 1R01AA01809501 Platelets and the Blood
Brain Barrier
INVESTIGATORS
Miguez, Nair
DEPARTMENT
Florida International
University
SCIENTIFIC AREA
mechanisms. Building on our previous
findings and published data, our second
aim is to investigate the relationship
between platelet counts and levels of
platelet associated factors (PAF, BDNF,
serotonin) and neuropsychological
function in PLWH.
The main task of this project is to explore
the plausible role of platelets in the
disruption of the blood brain barrier
among PLWH and identify if factors
released from apoptotic platelets may be
underpinning the damage
VACCINE & GENE THERAPY INSTITUTE – FLORIDA – 7 Studies
Presenters: Rafick Pierre Sékaly, Ph.D. & Lydie Trautmann, Ph.D.
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
Investigating the impact of
homeostatic proliferation on
HIV persistence
The role of negative regulators
of T cell activation in the
maintenance of viral latency
Identifying the antigen
specificity of the latent
reservoir: A rationale for the
development of vaccine aimed
at activating HIV-specific CD4 T
cell
Understanding the first
immunological events in acute
HIV infection.
Dr. Sekaly, Dr. Chomont,
Dr. Cameron, Dr. Wilkinson
N/A
HIV reservoirs
Dr Chomont, Dr Sekaly
N/A
HIV reservoirs
Dr. Trautmann, Dr Sekaly,
Dr MBitikon-Kobo
VGTI-FL
Acute HIV infection
Systems biology approaches to
identify innate and adaptive
mucosal immune correlates of
protection from HIV infection
Dr. Trautmann, Dr.
MBitikon-Kobo, Dr. Fischl,
Dr. Castro and Dr. Pahwa
VGTI-FL, University of
Miami School of
Medicine
Mucosal immunity and HIV
Dr Chomont
HIV reservoirs
Rev. 9/29/11
FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
Page 83 of 84
STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
Screening of small molecules
aimed at reactivating HIV from
its latent reservoirs
Evasion of the innate immune
response by HIV-1
INVESTIGATORS
DEPARTMENT
SCIENTIFIC AREA
Dr Chomont, Dr. Sekaly
VGTI and Merck
HIV reservoirs
John Hiscott
VGTI Microbiology &
Immunology and
McGill University
Antiviral signaling is inhibited in HIV-1 infection
by a protease-mediated sequestration of RIG-I
(Solis et al, J. Virol. 85:1224-1236, 2011)
BROWARD CHILDREN’S DIAGNOSTIC & TREATMENT CENTER - 2 Studies
Presented by Ana Puga, M.D.
BASIC SCIENCE/VIROLOGY
BEHAVIORAL/EPIDEMIOLOGICAL
BASIC SCIENCE/VIROLOGY
ATN 081: Treatment DeIntensification and Residual
HIV-1 in Adolescents and Young
Adults (on-going)
IMPAACT P1085 : Duration of
Human Papilloma Virus (HPV)
Type-Specific Antibody After
Administration of Quadrivalent
HPV Vaccine to HIV-1 Infected
Children Preciously Enrolled in
IMPAACT P1047 (recruiting)
Ana Puga, MD
CFAP Research
Residual Viral Load in patients in Highly
Active Antiretroviral Therapy (HAART)
deintensification
Ana Puga, MD
CFAP Research
Duration of HPV antibodies postvaccination
ClinicalTrials.gov Website Studies – 4 Additional Studies
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
Safety and Effectiveness of
Raltegravir (MK-0518) in
Treatment-Experienced, HIVInfected Children and Adolescents
Pilot Assessment of
Lopinavir/Ritonavir and Maraviroc
in Experienced Patients
NCT00981318
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID)
Sharon A. Nachman, MD, State
University of New York at Stony
Brook, Health Science Center;
Andrew Wiznia, MD, Jacobi
Medical Center, Albert Einstein
College of Medicine
Abbott,
Barry M. Rodwick, M. D.
Termination from treatment due to suspected drug reaction attributable to
the study
medication; Grade 3 or 4 adverse events; Pharmacokinetic parameters; HIV
viral load; CD4 count and percentage;
Genotypic and phenotypic resistance measures
Recruiting: Jacksonville, Miami, Ft. Lauderdale, Tampa
This is a study to assess the response of lopinavir/ritonavir plus maraviroc
(with no nucleoside medications) in HIV patients failing their initial antiviral
therapy.
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FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)
INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
Page 84 of 84
STUDY CATEGORY
BASIC SCIENCE/VIROLOGY
CLINICAL TRIAL
BASIC SCIENCE/VIROLOGY
PROJECT TITLE
Phase 2, Randomized, Placebocontrolled Trial to Evaluate the
Safety and Effect on Post-HIV
Acquisition Viremia of a Multiclade
HIV-1 DNA Plasmid Vaccine
Followed by a Multiclade HIV-1
Recombinant Adenoviral Vector
Vaccine in HIV-Uninfected,
Adenovirus Type 5 Neutralizing
Antibody Negative, Circumcised
Men and Male-to-Female (MTF)
Transgender Persons, Who Have
Sex With Men
NCT00865566
Safety and Immunogenicity of
GlaxoSmithKline Biologicals' Herpes
Zoster Vaccine 1437173A in Adult
HIV-infected Subjects
NCT01165203
INVESTIGATORS
Scott Hammer,
Magdalena Sobieszczyk,
Michael Yin – Columbia
University;
Orlando Immunology Center
HVTN CRS - Jeffrey Dinsmore,
DEPARTMENT
SCIENTIFIC AREA
The purpose of this study is to determine the safety and efficacy of a VRC
DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female
(MTF) transgender persons who have sex with men.
RN
NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS
DISEASES (NIAID),
HIV VACCINE TRIALS NETWORK
GSK Clinical Trials
877-379-3718
GSKClinicalSupportHD@gsk.com
877-379-3718
This observer-blind study will evaluate the safety and immunogenicity of
GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine
GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly
enrolling subjects treated with antiretroviral therapy (ART) and with high CD4
T cell counts, and subsequently ART-treated subjects with low CD4 T cell
counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol
Posting has been updated following Amendment 1 of the Protocol, August
2010. The impacted section is exclusion criteria.
TOTAL NUMBER OF BASIC SCIENCE STUDIES LISTED AS OF 9/29/11 = 91
GRAND TOTAL NUMBER OF STUDIES LISTED AS OF 9/29/11 = 412
Rev. 9/29/11